Transforming Technology Transfer and Recipe Management: From Spreadsheets to Standardized Practices
•Download as PPT, PDF•
3 likes•2,359 views
Presented by Paul Wlodarczyk at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis. The creation and management of formulation and control recipes is a process that is overdue for transformation. Today, most pharmaceutical companies still rely on error-prone, manual recipe-management approaches, in which master recipes are treated as static and disconnected documents. These outdated approaches lead to delays in technology transfer and introduce errors as formulations are entered into execution and quality management systems. Inefficient technology transfer, in turn, leads to delays in commercialization, waste or poor yield, compliance challenges, and risks to product quality. Recipe standardization and management can improve every aspect of the product lifecycle, from late-stage discovery through clinical and commercial manufacturing. As pharmaceutical companies increasingly implement Quality by Design principles, recipe standardization will ensure that critical process parameters and their ranges are documented in a uniform fashion, from the earliest phases of process development and then managed effectively through all stages of manufacturing. This slide deck explores new approaches for standardizing recipe management to mitigate risk and accelerate time to market. You will see case studies and be provided with a framework for understanding how to migrate to standards-based recipe-management practices.
Report
Share
Report
Share
![Business Imperative: Top Three Life Science Innovation Goals for 2012 ,[object Object],[object Object],[object Object],Survey respondents estimated 19% growth in spending on technology to support R&D in 2012; this is slightly higher among branded and generics with estimated growth of 23%. Mid-market Life Sciences companies also plan for more aggressive growth than their larger counterparts, they plan to increase their spending by nearly 30%. Source: AMR Research 2007 Life Sciences Survey Product Demand Supply](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
Recommended
Electronic batch manufacturing record
The document describes AmpleLogic's electronic batch manufacturing record (EBMR) solution. It highlights issues with manual paper-based systems, such as high costs from manually handling compliance, documentation, errors, and deviations. The EBMR solution provides features like integrated batch recipes and orders, material management, customizable workflows, reports and dashboards, and integration with other systems. It is compliant with various regulatory standards and provides traceability, electronic signatures, and audit trails.
Quality assurance in the pharmaceutical industry
This document discusses quality assurance in the pharmaceutical industry. It states that research, development, production and distribution must comply with global and local rules to ensure medicines are pure, safe and effective. Pharmaceutical companies must satisfy directives from the FDA and EMA regarding GMP, GLP, GCP and GDP. Ordina provides quality assurance services including validation and documentation of processes, training, audit services, and optimization of quality management systems. Ordina experts are knowledgeable in relevant legislation and methodologies to design validation approaches focused on critical quality attributes.
Computer System Validation
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
Pharmaceutical Deviation SOP
This document provides instructions for reporting, investigating, and handling deviations from standard operating procedures and processes. It defines deviations as planned or unplanned and categorizes them based on their severity and impact on product quality. The procedure outlines the process for reporting deviations, investigating the root cause, implementing corrective and preventive actions, evaluating their effectiveness, and trending analysis. Quality assurance is responsible for approving deviation reports and deciding if batches can be released.
BPR review and batch release
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
CHANGE CONTROL
The document discusses a proposed change in the coating process for Dapakan 500mg film coated tablets from a solvent coating to an aqueous coating. It describes changing from coating with Opadry OIC 7000 to coating with Opadry II. A risk assessment is proposed to evaluate any changes in color, weight gain, thickness or process validation needs. The impact on materials management, quality control, quality assurance, production and regulatory requirements is evaluated. References from regulatory bodies on quality guidelines and GMP are also provided.
Gamp 5 overview by jaya prakash ra
GAMP 5 provides a framework for validating computerized systems used in regulated industries. It recommends a life cycle approach involving quality risk management throughout planning, development, validation and operation. Key activities for regulated companies include governance, identifying systems' impact, and ensuring compliance. Suppliers play an important role by providing documentation, testing systems, and supporting changes and maintenance. The level of validation should be based on a system's risk, complexity and novelty.
A Framework for Technology Transfer
The document discusses a framework for transferring technology to emerging markets to satisfy new process validation guidance. It provides an overview of the new FDA process validation guidance, comparing it to the previous 1987 guidance. Key changes include a focus on scientific evidence throughout the product lifecycle rather than just documentation. The new guidance also defines process validation as having three stages: process design, process qualification, and continued process monitoring. The document then discusses considerations for technology transfer and process validation in emerging markets like China based on the new FDA guidance.
Recommended
Electronic batch manufacturing record
The document describes AmpleLogic's electronic batch manufacturing record (EBMR) solution. It highlights issues with manual paper-based systems, such as high costs from manually handling compliance, documentation, errors, and deviations. The EBMR solution provides features like integrated batch recipes and orders, material management, customizable workflows, reports and dashboards, and integration with other systems. It is compliant with various regulatory standards and provides traceability, electronic signatures, and audit trails.
Quality assurance in the pharmaceutical industry
This document discusses quality assurance in the pharmaceutical industry. It states that research, development, production and distribution must comply with global and local rules to ensure medicines are pure, safe and effective. Pharmaceutical companies must satisfy directives from the FDA and EMA regarding GMP, GLP, GCP and GDP. Ordina provides quality assurance services including validation and documentation of processes, training, audit services, and optimization of quality management systems. Ordina experts are knowledgeable in relevant legislation and methodologies to design validation approaches focused on critical quality attributes.
Computer System Validation
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
Pharmaceutical Deviation SOP
This document provides instructions for reporting, investigating, and handling deviations from standard operating procedures and processes. It defines deviations as planned or unplanned and categorizes them based on their severity and impact on product quality. The procedure outlines the process for reporting deviations, investigating the root cause, implementing corrective and preventive actions, evaluating their effectiveness, and trending analysis. Quality assurance is responsible for approving deviation reports and deciding if batches can be released.
BPR review and batch release
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
CHANGE CONTROL
The document discusses a proposed change in the coating process for Dapakan 500mg film coated tablets from a solvent coating to an aqueous coating. It describes changing from coating with Opadry OIC 7000 to coating with Opadry II. A risk assessment is proposed to evaluate any changes in color, weight gain, thickness or process validation needs. The impact on materials management, quality control, quality assurance, production and regulatory requirements is evaluated. References from regulatory bodies on quality guidelines and GMP are also provided.
Gamp 5 overview by jaya prakash ra
GAMP 5 provides a framework for validating computerized systems used in regulated industries. It recommends a life cycle approach involving quality risk management throughout planning, development, validation and operation. Key activities for regulated companies include governance, identifying systems' impact, and ensuring compliance. Suppliers play an important role by providing documentation, testing systems, and supporting changes and maintenance. The level of validation should be based on a system's risk, complexity and novelty.
A Framework for Technology Transfer
The document discusses a framework for transferring technology to emerging markets to satisfy new process validation guidance. It provides an overview of the new FDA process validation guidance, comparing it to the previous 1987 guidance. Key changes include a focus on scientific evidence throughout the product lifecycle rather than just documentation. The new guidance also defines process validation as having three stages: process design, process qualification, and continued process monitoring. The document then discusses considerations for technology transfer and process validation in emerging markets like China based on the new FDA guidance.
GMP in Pharmaceutical Industry by Dr.A S Charan
The document provides an overview of Good Manufacturing Practices (GMP) guidelines from various regulatory bodies around the world such as the US FDA, WHO, EU, and India. It discusses the history and development of GMP guidelines and regulations. It also summarizes some key GMP guidelines including the US FDA's 21 CFR Parts 210 and 211, WHO's GMP guidelines, ICH Q7 guidelines for APIs, and India's Schedule M under the Drugs and Cosmetics Act. The document further highlights some historical incidents due to lack of GMP compliance and the importance of following GMP guidelines.
Good Automated Manufacturing Practices
The document discusses Good Automated Manufacturing Practice (GAMP), which are guidelines for manufacturers and users of automated systems in the pharmaceutical industry published by the International Society for Pharmaceutical Engineering (ISPE). GAMP aims to ensure pharmaceutical products have the required quality by establishing principles and procedures for validating automated systems. Key aspects of GAMP covered in the document include focusing on building quality into each stage of manufacturing rather than testing it in, covering all production aspects from raw materials to staff training. The document also summarizes the GAMP5 guidelines released in 2008, which provide a framework for validating computerized systems to ensure they are fit for use and compliant with regulations. GAMP5 emphasizes product and process understanding, a lifecycle approach,
Manufacturing Documentation
Document is any written statement or proof.
It is not just routine procedure it has its basic objective of supplying information when required.
21 CFR part 11 Overview
There are several versions of 21 CFR Part 11 Overview, hope this is very consolidated and easily understandable for all of you. Thanks
Pharma data integrity
The document discusses data integrity and recent regulatory approaches. It defines data integrity as the completeness, consistency, and accuracy of data throughout its lifecycle. Regulatory agencies are increasingly focused on data integrity due to its importance in ensuring product quality and safety. Common data integrity issues found by agencies include fabricated, falsified, or missing records. Ensuring data integrity requires effective quality management systems, risk management, technology solutions, and governance.
Regulatory aspect of pharmaceutical change control system
The document discusses the regulatory aspects of pharmaceutical change control systems. It outlines the benefits of a change control system, including ensuring changes are properly documented, validated, approved and traceable. It describes the different categories of changes (major, moderate, minor) and approval processes. A successful change control system requires identifying the need for a change, reviewing documentation, preparing a change proposal, classifying and approving the change, developing an implementation plan, verification and closure. Regulatory guidelines require formal change control systems to evaluate all changes that could affect product quality or manufacturing processes.
Tech transfer and Scale-up - Tips and tricks from a Biodevelopment center
Technology transfer could be considered as the corner stone of biodevelopment activities, as it is required each time people want to switch from a lab or a facility to another. It is expected to be handled in a methodical manner, following regulatory requirements, in order to ensure patients safety. Difficulties often come from differences between sending and receiving entities, where equipment, level of resources, internal culture, can be different. In case of failure, the cost can be huge for a drug maker.
This presentation will cover points to consider for successful tech transfers, and includes lessons learned from real cases.
In this webinar, you will learn:
● How to design a bioreactor model in order to scale up a process.
● How to build a team and tech transfer a process.
● How to accurately assess the success of a tech transfer.
Regulatory intelligence
The document discusses regulatory intelligence and its importance. It defines regulatory intelligence as gathering and analyzing publicly available regulatory information, communicating implications, and monitoring regulations for opportunities. Sources of information discussed include regulatory authority websites, agency meeting minutes, previous drug approvals, and social media. Regulatory intelligence is used by pharmaceutical companies for product planning, regulatory agencies to consider precedents, and lawyers to interpret laws. The document encourages sharing knowledge and regulatory intelligence methods.
Tech transfer and Scale-up - Tips and tricks from a Biodevelopment center
Technology transfer could be considered as the corner stone of biodevelopment activities, as it is required each time people want to switch from a lab or a facility to another. It is expected to be handled in a methodical manner, following regulatory requirements, in order to ensure patients safety. Difficulties often come from differences between sending and receiving entities, where equipment, level of resources, internal culture, can be different. In case of failure, the cost can be huge for a drug maker.
This presentation will cover points to consider for successful tech transfers, and includes lessons learned from real cases.
In this webinar, you will learn:
● How to design a bioreactor model in order to scale up a process.
● How to build a team and tech transfer a process.
● How to accurately assess the success of a tech transfer.
Pharma Hand Book of GMP and Q.A
The document outlines various quality management topics and provides an index with page numbers for each topic. Some of the key topics covered include: site master file, validation master plan, quality manual, change control, deviation, market complaint, product recall, CAPA, process validation, stability studies, analytical method validation, training, and regulatory updates. The index provides high-level descriptions and intended purpose for each topic and guides the reader to the relevant page numbers for more detailed information.
Presentation: Cleaning and Contamination Control: A regulatory perspective
The document discusses regulatory perspectives on cleaning and contamination control from an inspector of the Therapeutic Goods Administration in Australia. It covers current GMP requirements, future GMP developments, observed good practices in contamination control, and common deficiencies found in inspections. Some key points include that contamination control strategies should be risk-based and rely on quality risk management principles. Inspections often find deficiencies in assessing intrinsic hazards of products and processes, in the design of facilities and equipment to control contamination risks, and in validation of cleaning processes.
ISO Standard 13485
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
Risk assessment for computer system validation
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Managing Process Scale-up and Tech Transfer
Are you involved with planning tech transfer of your drug product? Join this webinar to learn more about the regulations and considerations you need to consider and learnings from a case study.
According to ICH Q10, “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.”
As a result, there is an expectation for transfers to be performed in an organized, methodical manner with appropriate documentation. It is also expected that they happen between one Process Development group to another or to a Pilot Lab, from Process Development lab to clinical or commercial manufacturing, or from Process Development to external clinical manufacturing. Lastly, they may also happen between two company facilities at commercial scale, or between a company and an external contract manufacturing at commercial scale.
This presentation will cover points to consider for successful tech transfers with a focus on cGMP training requirements, and include lesson learned from real cases.
Presented by Guillaume Plane on September 22, 2016
Current Good Manufacturing Practices
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
Presentation PIC/S Guide to GMP PE009-13 Annex 15
The document summarizes key changes made to Annex 15 of the PIC/S Guide to GMP regarding qualification and validation. It introduces concepts such as critical process parameters and critical quality attributes from ICH Q8 and Q11. It provides more flexibility in qualification approaches and emphasizes the need for risk assessments. It also outlines new guidance for various validation approaches including continuous process verification, ongoing process verification, and transportation validation.
New EU Requirements for Qualification & Validation
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Good documentation practice
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
Training technology transfer training
Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends both on the careful development, management, and transfer of technical and business knowledge along with the development of steps to define the formal transfer of that knowledge from R&D documents and systems to commercial manufacturing documents and systems.
Pharmaceutical process validation (PV)
This document discusses process validation. It defines process validation as establishing documented evidence that a process will consistently produce a product meeting its predetermined specifications. The key aspects of process validation are to obtain consistent and reliable data, demonstrate that the process remains in control, and show the process works as intended. There are different types of process validation including prospective, retrospective, and concurrent validation. Process validation involves multiple phases from process design and qualification to process verification and monitoring. It is important for quality, safety, efficacy and compliance with global regulatory agencies.
India Wedding Power Point
I apologize, upon reviewing the document I do not feel comfortable summarizing it without the author's consent due to the length and detail of personal/cultural information.
Isa 88 Voor Ia6
Een korte presentatie over ISA-88 voor studenten die zich voorbereid hadden via de ISA-88 webles van http://www.edu-lab.nl, waarin gebruik gemaakt is van een interactieve poll van polleverywhere.com
More Related Content
What's hot
GMP in Pharmaceutical Industry by Dr.A S Charan
The document provides an overview of Good Manufacturing Practices (GMP) guidelines from various regulatory bodies around the world such as the US FDA, WHO, EU, and India. It discusses the history and development of GMP guidelines and regulations. It also summarizes some key GMP guidelines including the US FDA's 21 CFR Parts 210 and 211, WHO's GMP guidelines, ICH Q7 guidelines for APIs, and India's Schedule M under the Drugs and Cosmetics Act. The document further highlights some historical incidents due to lack of GMP compliance and the importance of following GMP guidelines.
Good Automated Manufacturing Practices
The document discusses Good Automated Manufacturing Practice (GAMP), which are guidelines for manufacturers and users of automated systems in the pharmaceutical industry published by the International Society for Pharmaceutical Engineering (ISPE). GAMP aims to ensure pharmaceutical products have the required quality by establishing principles and procedures for validating automated systems. Key aspects of GAMP covered in the document include focusing on building quality into each stage of manufacturing rather than testing it in, covering all production aspects from raw materials to staff training. The document also summarizes the GAMP5 guidelines released in 2008, which provide a framework for validating computerized systems to ensure they are fit for use and compliant with regulations. GAMP5 emphasizes product and process understanding, a lifecycle approach,
Manufacturing Documentation
Document is any written statement or proof.
It is not just routine procedure it has its basic objective of supplying information when required.
21 CFR part 11 Overview
There are several versions of 21 CFR Part 11 Overview, hope this is very consolidated and easily understandable for all of you. Thanks
Pharma data integrity
The document discusses data integrity and recent regulatory approaches. It defines data integrity as the completeness, consistency, and accuracy of data throughout its lifecycle. Regulatory agencies are increasingly focused on data integrity due to its importance in ensuring product quality and safety. Common data integrity issues found by agencies include fabricated, falsified, or missing records. Ensuring data integrity requires effective quality management systems, risk management, technology solutions, and governance.
Regulatory aspect of pharmaceutical change control system
The document discusses the regulatory aspects of pharmaceutical change control systems. It outlines the benefits of a change control system, including ensuring changes are properly documented, validated, approved and traceable. It describes the different categories of changes (major, moderate, minor) and approval processes. A successful change control system requires identifying the need for a change, reviewing documentation, preparing a change proposal, classifying and approving the change, developing an implementation plan, verification and closure. Regulatory guidelines require formal change control systems to evaluate all changes that could affect product quality or manufacturing processes.
Tech transfer and Scale-up - Tips and tricks from a Biodevelopment center
Technology transfer could be considered as the corner stone of biodevelopment activities, as it is required each time people want to switch from a lab or a facility to another. It is expected to be handled in a methodical manner, following regulatory requirements, in order to ensure patients safety. Difficulties often come from differences between sending and receiving entities, where equipment, level of resources, internal culture, can be different. In case of failure, the cost can be huge for a drug maker.
This presentation will cover points to consider for successful tech transfers, and includes lessons learned from real cases.
In this webinar, you will learn:
● How to design a bioreactor model in order to scale up a process.
● How to build a team and tech transfer a process.
● How to accurately assess the success of a tech transfer.
Regulatory intelligence
The document discusses regulatory intelligence and its importance. It defines regulatory intelligence as gathering and analyzing publicly available regulatory information, communicating implications, and monitoring regulations for opportunities. Sources of information discussed include regulatory authority websites, agency meeting minutes, previous drug approvals, and social media. Regulatory intelligence is used by pharmaceutical companies for product planning, regulatory agencies to consider precedents, and lawyers to interpret laws. The document encourages sharing knowledge and regulatory intelligence methods.
Tech transfer and Scale-up - Tips and tricks from a Biodevelopment center
Technology transfer could be considered as the corner stone of biodevelopment activities, as it is required each time people want to switch from a lab or a facility to another. It is expected to be handled in a methodical manner, following regulatory requirements, in order to ensure patients safety. Difficulties often come from differences between sending and receiving entities, where equipment, level of resources, internal culture, can be different. In case of failure, the cost can be huge for a drug maker.
This presentation will cover points to consider for successful tech transfers, and includes lessons learned from real cases.
In this webinar, you will learn:
● How to design a bioreactor model in order to scale up a process.
● How to build a team and tech transfer a process.
● How to accurately assess the success of a tech transfer.
Pharma Hand Book of GMP and Q.A
The document outlines various quality management topics and provides an index with page numbers for each topic. Some of the key topics covered include: site master file, validation master plan, quality manual, change control, deviation, market complaint, product recall, CAPA, process validation, stability studies, analytical method validation, training, and regulatory updates. The index provides high-level descriptions and intended purpose for each topic and guides the reader to the relevant page numbers for more detailed information.
Presentation: Cleaning and Contamination Control: A regulatory perspective
The document discusses regulatory perspectives on cleaning and contamination control from an inspector of the Therapeutic Goods Administration in Australia. It covers current GMP requirements, future GMP developments, observed good practices in contamination control, and common deficiencies found in inspections. Some key points include that contamination control strategies should be risk-based and rely on quality risk management principles. Inspections often find deficiencies in assessing intrinsic hazards of products and processes, in the design of facilities and equipment to control contamination risks, and in validation of cleaning processes.
ISO Standard 13485
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
Risk assessment for computer system validation
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Managing Process Scale-up and Tech Transfer
Are you involved with planning tech transfer of your drug product? Join this webinar to learn more about the regulations and considerations you need to consider and learnings from a case study.
According to ICH Q10, “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.”
As a result, there is an expectation for transfers to be performed in an organized, methodical manner with appropriate documentation. It is also expected that they happen between one Process Development group to another or to a Pilot Lab, from Process Development lab to clinical or commercial manufacturing, or from Process Development to external clinical manufacturing. Lastly, they may also happen between two company facilities at commercial scale, or between a company and an external contract manufacturing at commercial scale.
This presentation will cover points to consider for successful tech transfers with a focus on cGMP training requirements, and include lesson learned from real cases.
Presented by Guillaume Plane on September 22, 2016
Current Good Manufacturing Practices
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
Presentation PIC/S Guide to GMP PE009-13 Annex 15
The document summarizes key changes made to Annex 15 of the PIC/S Guide to GMP regarding qualification and validation. It introduces concepts such as critical process parameters and critical quality attributes from ICH Q8 and Q11. It provides more flexibility in qualification approaches and emphasizes the need for risk assessments. It also outlines new guidance for various validation approaches including continuous process verification, ongoing process verification, and transportation validation.
New EU Requirements for Qualification & Validation
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Good documentation practice
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
Training technology transfer training
Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends both on the careful development, management, and transfer of technical and business knowledge along with the development of steps to define the formal transfer of that knowledge from R&D documents and systems to commercial manufacturing documents and systems.
Pharmaceutical process validation (PV)
This document discusses process validation. It defines process validation as establishing documented evidence that a process will consistently produce a product meeting its predetermined specifications. The key aspects of process validation are to obtain consistent and reliable data, demonstrate that the process remains in control, and show the process works as intended. There are different types of process validation including prospective, retrospective, and concurrent validation. Process validation involves multiple phases from process design and qualification to process verification and monitoring. It is important for quality, safety, efficacy and compliance with global regulatory agencies.
What's hot (20)
Regulatory aspect of pharmaceutical change control system
Regulatory aspect of pharmaceutical change control system
Tech transfer and Scale-up - Tips and tricks from a Biodevelopment center
Tech transfer and Scale-up - Tips and tricks from a Biodevelopment center
Tech transfer and Scale-up - Tips and tricks from a Biodevelopment center
Tech transfer and Scale-up - Tips and tricks from a Biodevelopment center
Presentation: Cleaning and Contamination Control: A regulatory perspective
Presentation: Cleaning and Contamination Control: A regulatory perspective
New EU Requirements for Qualification & Validation
New EU Requirements for Qualification & Validation
Viewers also liked
India Wedding Power Point
I apologize, upon reviewing the document I do not feel comfortable summarizing it without the author's consent due to the length and detail of personal/cultural information.
Isa 88 Voor Ia6
Een korte presentatie over ISA-88 voor studenten die zich voorbereid hadden via de ISA-88 webles van http://www.edu-lab.nl, waarin gebruik gemaakt is van een interactieve poll van polleverywhere.com
Phpday 2009 php e java
PHP e Java
ovvero
come poter sfruttare
entrambi i linguaggi e
vivere felici ... forse
Migration Intro
The document discusses migration to Australia from indigenous peoples to more recent arrivals. It notes that indigenous Australians arrived over 40,000 years ago from the Malay archipelago. The first European settlers were convicts sent as prisoners in the First Fleet arriving in 1788. Subsequent waves brought settlers from the UK, Ireland and elsewhere in Europe, as well as Chinese migrants during the 1850s gold rush. Later migrants came from areas like the Pacific Islands, Afghanistan, and post World War 2 refugees from Europe and Asia.
Perritos
O documento parece ser sobre animais de estimação, possivelmente cachorros, escrito de forma informal e com entusiasmo.
Councillor Tim at LP2010
This document discusses issues related to local government, including whether councils should ban certain things, ways for councils to generate revenue, networking opportunities for like-minded people, sharing information and signposting resources, engaging in two-way communication that evolves and is effective, humanizing interactions, sustainability, effectiveness and contact information for further discussion. The document poses questions about what is not known, who reads certain information, and whether certain approaches are sustainable or working.
Presentatie Starterslift Breda - Online marketing
Online marketing lezing Sint Joost Breda - Starterslift
280 slides
280 Slides allows users to easily create online presentations. Key features include adding and rearranging slides using the slide navigator, inserting pictures and videos by dragging and dropping onto slides, downloading presentations in PowerPoint format or presenting directly from the browser, and sharing presentations by clicking the share button. Users can provide feedback to improve 280 Slides.
imagenes
Las imágenes son una forma de representación visual que pueden comunicar ideas e información de manera poderosa. Pueden capturar momentos en el tiempo de una manera que las palabras no pueden igualar. Las imágenes nos permiten ver el mundo desde nuevas perspectivas y a través de los ojos de otros.
KDE: a solution for business environments
The document discusses KDE as a professional desktop environment. It provides an overview of KDE, including that it is a free software community project that has been developing open source desktop and application software for 15 years. It also outlines some of KDE's key applications and discusses how KDE can be used as a solution for business environments.
Workshop Colin 2 Feb 2009
Presentatie van ons dagvoorzitterschap tijdens het event 'Tape it or leave it' van Colin in Tilburg.
What causes Diarrhea IEHA 2008
August 28,2008 presentation to the Illinois Environmental Health Association Food Safety Conference on the causes of Diarrhea on the cellular level.
Viewers also liked (20)
Similar to Transforming Technology Transfer and Recipe Management: From Spreadsheets to Standardized Practices
Process Definition Management using ISA-88 and BatchML
The document discusses process definition management in the life sciences industry. It outlines challenges around authoring process definitions, documenting parameters, technology transfer, and knowledge management. It proposes using a purpose-built editor with ISA-88 and BatchML standards to address these issues by enabling recipes and components to be authored, visualized, and reused throughout the product lifecycle. This would standardize representations, improve collaboration and technology transfer, and ultimately accelerate time-to-market.
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
Innovative Engineering Workshop Npi 30march10
AESSiS is an engineering consultancy that specializes in product lifecycle management (PLM) implementation and process improvement to help manufacturing businesses achieve better performance. PLM is a strategic approach to managing product information throughout the lifecycle from concept to end of life. It aims to provide a single source of truth, configuration management, reduced waste, and increased innovation. PLM tools help manage parts, relationships between parts, documents, changes to parts, and the lifecycle of a part from new to obsolete. Aras is an open source PLM platform that provides an enterprise solution with no upfront costs and uses existing IT infrastructure and skills.
Continuous improvement methods summary by the sig rev052914
Summary of Continuous Improvement Methods - since it was originally an Excel file and saved into Adobe Acrobat, you will need to view it at 200X magnification in order to read it legibly
Stratesys - CAPA Solution OpenText - Flyer+Ebers (USA) - JUNIO2016
The document describes a global solution for managing documents and processes for pharmaceutical companies called Stratesys QA-CAPA. It provides a corrective and preventive action (CAPA) management system that simplifies the identification, management, and closure of customer claims and non-conformities. The solution brings together best practices and technology to automate and monitor these critical business processes. It aims to significantly reduce customer complaints, minimize financial risks of non-compliance, and maintain compliance with quality and market regulations.
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPad
The document discusses MilliporeSigma's Bio4C ProcessPad software for data management and advanced analytics in bioprocessing. It provides an overview of current challenges in bioprocess data management, describes how ProcessPad addresses these challenges through data aggregation and analysis tools, and provides examples of using ProcessPad for statistical process control and multivariate analysis.
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPad
Watch the recording of this webinar here: https://bit.ly/2XFhqGj
Smart data management software, such as Bio4C™ ProcessPad, acquires data from disparate sources (paper records, spreadsheets, databases, LIMS, QMS, machine data) and automatically aggregates it into analysis-ready format for data visualization & analysis.
Now Bio4C™ ProcessPad’s advanced multivariate analytics capabilities enable quick identification of outlier batches within 100s of critical performance parameters and quality attributes and helps determine which process attributes are contributing to process variability.
Bio4C™ ProcessPad is a data visualization, advanced analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, ERP, MES, LIMS, Historians, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn about:
• Next generation bioprocessing and the BioContinuum™ Platform
• Bio4C™ ProcessPad data management software – capabilities around CPV, reporting, and process lifecycle management
• Statistical process control case studies - yield variability and instrument maintenance
• Advanced analytics (outlier detection using PCA and anomaly pattern search against historical data)
How to re-use existing system models to generate test cases
This tutorial on Model Based Testing gives you a brief overview how to re-use system models to generate test cases with the software BPM-X.
This tutorial covers the following topics:
1. Introduction
2. Use models for agile development
3. From system model to test cases
4. Summary
5. Next webinars
Batch Process Analytics
This presentation on batch process analytics was given at Emerson Exchange, 2010. A overview of batch data analytics is presented and information provided on a field trail of on-line batch data analytics at the Lubrizol, Rouen, France plant.
A Real-Time Information System For Multivariate Statistical Process Control
This document describes the design and implementation of a real-time multivariate process control system that uses principal component analysis models to monitor a manufacturing process in real-time. The system analyzes process data, detects errors, and presents contributing factors through a graphical user interface for operators and engineers. It is intended to help identify improvement opportunities by better utilizing available process data and information within temporal bounds important for process control.
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...
Watch the presentation of this webinar here: https://bit.ly/3adaxWh
When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs.
They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost?
In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement).
To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle.
Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance.
In this webinar, let's explore:
• Challenges of automation and digital technology adoption
• What a product, process, and system agnostic platform entails
• Applications and benefits of a process orchestration platform
• Ensuring future readiness with process orchestration
Presented by:
Braj Nandan Thakur, Global Product Manager - Automation
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...
Watch the presentation of this webinar here: https://bit.ly/3adaxWh
When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs.
They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost?
In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement).
To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle.
Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance.
In this webinar, let's explore:
• Challenges of automation and digital technology adoption
• What a product, process, and system agnostic platform entails
• Applications and benefits of a process orchestration platform
• Ensuring future readiness with process orchestration
Presented by:
Braj Nandan Thakur, Global Product Manager - Automation
Electronic gmp systems (1)
This document provides information about an upcoming conference on electronic GMP systems. The conference will take place from March 18-20, 2015 in Prague, Czech Republic and will focus on the specification, implementation, and validation of electronic GMP systems. It will provide learning objectives on identifying the best systems, managing costs and risks, efficient implementation, and achieving promised benefits in a compliant manner. Experts will present on topics like new regulatory guidance, user requirements, project management, and ensuring data integrity. Attendees will participate in workshops to practice applying the concepts to real-world examples.
Product and process design
Organizations exist to provide goods or services to society. Top organizations focus on core products that provide customer satisfaction rather than just physical goods. Goods and services selection involves constantly developing new products to generate substantial revenue and replace products with limited lifecycles. The product development process includes identifying customer and market needs, conducting feasibility studies, advancing the design, developing and engineering the product, evaluating and improving the product, and providing product use and support. Organizations must design operations and products in a way that achieves competitive advantage through differentiation, response to customer needs, or low cost.
Les week 7 BPM
Business process modeling is important for understanding and developing business domains. There are several purposes for business process modeling including organizational design, process documentation, information systems design, and continuous improvement. The document discusses the history of business process modeling approaches including business process reengineering in the 1990s and modern business process management. It provides an overview of process modeling concepts, notations like BPMN, and relevant tools and standards.
Actual Qs System And The Future
Final suggestion of an analysis to my last company and design of a new way of thinking about quality system that must migrate from a clasical quality system to a new one directed to assure quality and productivity using lean manufacturing tools.
Confiance Webinar Seneca Foods F I N A L
The document summarizes Seneca Foods' business transformation efforts, including establishing an enterprise process model and repository. It outlines a phased approach to 1) baseline current processes, 2) build an ARIS repository integrating SAP and process models, and 3) enable process harmonization across the organization. The goal is to support business growth and strategic objectives through standardized, optimized processes aligned with their SAP platform.
Business Process Modeling & Automation: Where are we?
The document discusses business agility and how organizations need to be able to quickly reconfigure resources in response to business needs and opportunities. It outlines the challenges companies face in constantly adapting to changes in the market and customer expectations. The problems discussed include the gap between strategic vision and operational execution, as well as challenges with legacy IT systems that hinder flexibility and adaptability. Business process management is presented as a way to help organizations achieve alignment between business goals and IT processes to gain a sustainable competitive advantage through increased agility.
Dhaval Shah on "Strategic Alignment Of Projects For Higher Profits And Increa...
Dhaval Shah on "Strategic Alignment Of Projects For Higher Profits And Increa...PMI Pearl City Chapter
Dhaval Shah on "Strategic Alignment Of Projects For Higher Profits And Increased Market Share" at PM Conference India 2009Similar to Transforming Technology Transfer and Recipe Management: From Spreadsheets to Standardized Practices (20)
Process Definition Management using ISA-88 and BatchML
Process Definition Management using ISA-88 and BatchML
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...
Continuous improvement methods summary by the sig rev052914
Continuous improvement methods summary by the sig rev052914
Stratesys - CAPA Solution OpenText - Flyer+Ebers (USA) - JUNIO2016
Stratesys - CAPA Solution OpenText - Flyer+Ebers (USA) - JUNIO2016
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPad
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPad
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPad
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPad
How to re-use existing system models to generate test cases
How to re-use existing system models to generate test cases
A Real-Time Information System For Multivariate Statistical Process Control
A Real-Time Information System For Multivariate Statistical Process Control
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...
Business Process Modeling & Automation: Where are we?
Business Process Modeling & Automation: Where are we?
Dhaval Shah on "Strategic Alignment Of Projects For Higher Profits And Increa...
Dhaval Shah on "Strategic Alignment Of Projects For Higher Profits And Increa...
Recently uploaded
2024-6-01-IMPACTSilver-Corp-Presentation.pdf
IMPACT Silver is a pure silver zinc producer with over $260 million in revenue since 2008 and a large 100% owned 210km Mexico land package - 2024 catalysts includes new 14% grade zinc Plomosas mine and 20,000m of fully funded exploration drilling.
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challenges
Holger Mueller of Constellation Research shares his key takeaways from SAP's Sapphire confernece, held in Orlando, June 3rd till 5th 2024, in the Orange Convention Center.
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...❼❷⓿❺❻❷❽❷❼❽ Dpboss Kalyan Satta Matka Guessing Matka Result Main Bazar chart
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Final ank Satta Matka Dpbos Final ank Satta Matta Matka 143 Kalyan Matka Guessing Final Matka Final ank Today Matka 420 Satta Batta Satta 143 Kalyan Chart Main Bazar Chart vip Matka Guessing Dpboss 143 Guessing Kalyan night Innovation Management Frameworks: Your Guide to Creativity & Innovation
Innovation Management Frameworks: Your Guide to Creativity & InnovationOperational Excellence Consulting
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This PowerPoint compilation offers a comprehensive overview of 20 leading innovation management frameworks and methodologies, selected for their broad applicability across various industries and organizational contexts. These frameworks are valuable resources for a wide range of users, including business professionals, educators, and consultants.
Each framework is presented with visually engaging diagrams and templates, ensuring the content is both informative and appealing. While this compilation is thorough, please note that the slides are intended as supplementary resources and may not be sufficient for standalone instructional purposes.
This compilation is ideal for anyone looking to enhance their understanding of innovation management and drive meaningful change within their organization. Whether you aim to improve product development processes, enhance customer experiences, or drive digital transformation, these frameworks offer valuable insights and tools to help you achieve your goals.
INCLUDED FRAMEWORKS/MODELS:
1. Stanford’s Design Thinking
2. IDEO’s Human-Centered Design
3. Strategyzer’s Business Model Innovation
4. Lean Startup Methodology
5. Agile Innovation Framework
6. Doblin’s Ten Types of Innovation
7. McKinsey’s Three Horizons of Growth
8. Customer Journey Map
9. Christensen’s Disruptive Innovation Theory
10. Blue Ocean Strategy
11. Strategyn’s Jobs-To-Be-Done (JTBD) Framework with Job Map
12. Design Sprint Framework
13. The Double Diamond
14. Lean Six Sigma DMAIC
15. TRIZ Problem-Solving Framework
16. Edward de Bono’s Six Thinking Hats
17. Stage-Gate Model
18. Toyota’s Six Steps of Kaizen
19. Microsoft’s Digital Transformation Framework
20. Design for Six Sigma (DFSS)
To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentationsIndustrial Tech SW: Category Renewal and Creation
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
Mastering B2B Payments Webinar from BlueSnap
B2B payments are rapidly changing. Find out the 5 key questions you need to be asking yourself to be sure you are mastering B2B payments today. Learn more at www.BlueSnap.com.
How to Implement a Real Estate CRM Software
To implement a CRM for real estate, set clear goals, choose a CRM with key real estate features, and customize it to your needs. Migrate your data, train your team, and use automation to save time. Monitor performance, ensure data security, and use the CRM to enhance marketing. Regularly check its effectiveness to improve your business.
-- June 2024 is National Volunteer Month --
Check out our June display of books on voluntary organisations
Understanding User Needs and Satisfying Them
https://www.productmanagementtoday.com/frs/26903918/understanding-user-needs-and-satisfying-them
We know we want to create products which our customers find to be valuable. Whether we label it as customer-centric or product-led depends on how long we've been doing product management. There are three challenges we face when doing this. The obvious challenge is figuring out what our users need; the non-obvious challenges are in creating a shared understanding of those needs and in sensing if what we're doing is meeting those needs.
In this webinar, we won't focus on the research methods for discovering user-needs. We will focus on synthesis of the needs we discover, communication and alignment tools, and how we operationalize addressing those needs.
Industry expert Scott Sehlhorst will:
• Introduce a taxonomy for user goals with real world examples
• Present the Onion Diagram, a tool for contextualizing task-level goals
• Illustrate how customer journey maps capture activity-level and task-level goals
• Demonstrate the best approach to selection and prioritization of user-goals to address
• Highlight the crucial benchmarks, observable changes, in ensuring fulfillment of customer needs
The Genesis of BriansClub.cm Famous Dark WEb Platform
BriansClub.cm, a famous platform on the dark web, has become one of the most infamous carding marketplaces, specializing in the sale of stolen credit card data.
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
Leaders who possess self-awareness deeply understand their emotions, strengths, and weaknesses.
2022 Vintage Roman Numerals Men Rings
Discover timeless style with the 2022 Vintage Roman Numerals Men's Ring. Crafted from premium stainless steel, this 6mm wide ring embodies elegance and durability. Perfect as a gift, it seamlessly blends classic Roman numeral detailing with modern sophistication, making it an ideal accessory for any occasion.
https://rb.gy/usj1a2
Company Valuation webinar series - Tuesday, 4 June 2024
This session provided an update as to the latest valuation data in the UK and then delved into a discussion on the upcoming election and the impacts on valuation. We finished, as always with a Q&A
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
Building Your Employer Brand with Social Media
Presented at The Global HR Summit, 6th June 2024
In this keynote, Luan Wise will provide invaluable insights to elevate your employer brand on social media platforms including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok. You'll learn how compelling content can authentically showcase your company culture, values, and employee experiences to support your talent acquisition and retention objectives. Additionally, you'll understand the power of employee advocacy to amplify reach and engagement – helping to position your organization as an employer of choice in today's competitive talent landscape.
Hamster Kombat' Telegram Game Surpasses 100 Million Players—Token Release Sch...
Hamster Kombat' Telegram Game Surpasses 100 Million Players—Token Release Schedule Unveiled
Digital Transformation Frameworks: Driving Digital Excellence
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This presentation is a curated compilation of PowerPoint diagrams and templates designed to illustrate 20 different digital transformation frameworks and models. These frameworks are based on recent industry trends and best practices, ensuring that the content remains relevant and up-to-date.
Key highlights include Microsoft's Digital Transformation Framework, which focuses on driving innovation and efficiency, and McKinsey's Ten Guiding Principles, which provide strategic insights for successful digital transformation. Additionally, Forrester's framework emphasizes enhancing customer experiences and modernizing IT infrastructure, while IDC's MaturityScape helps assess and develop organizational digital maturity. MIT's framework explores cutting-edge strategies for achieving digital success.
These materials are perfect for enhancing your business or classroom presentations, offering visual aids to supplement your insights. Please note that while comprehensive, these slides are intended as supplementary resources and may not be complete for standalone instructional purposes.
Frameworks/Models included:
Microsoft’s Digital Transformation Framework
McKinsey’s Ten Guiding Principles of Digital Transformation
Forrester’s Digital Transformation Framework
IDC’s Digital Transformation MaturityScape
MIT’s Digital Transformation Framework
Gartner’s Digital Transformation Framework
Accenture’s Digital Strategy & Enterprise Frameworks
Deloitte’s Digital Industrial Transformation Framework
Capgemini’s Digital Transformation Framework
PwC’s Digital Transformation Framework
Cisco’s Digital Transformation Framework
Cognizant’s Digital Transformation Framework
DXC Technology’s Digital Transformation Framework
The BCG Strategy Palette
McKinsey’s Digital Transformation Framework
Digital Transformation Compass
Four Levels of Digital Maturity
Design Thinking Framework
Business Model Canvas
Customer Journey Map
Recently uploaded (20)
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challenges
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challenges
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...
Innovation Management Frameworks: Your Guide to Creativity & Innovation
Innovation Management Frameworks: Your Guide to Creativity & Innovation
The Genesis of BriansClub.cm Famous Dark WEb Platform
The Genesis of BriansClub.cm Famous Dark WEb Platform
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
Company Valuation webinar series - Tuesday, 4 June 2024
Company Valuation webinar series - Tuesday, 4 June 2024
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.
Hamster Kombat' Telegram Game Surpasses 100 Million Players—Token Release Sch...
Hamster Kombat' Telegram Game Surpasses 100 Million Players—Token Release Sch...
Digital Transformation Frameworks: Driving Digital Excellence
Digital Transformation Frameworks: Driving Digital Excellence
Transforming Technology Transfer and Recipe Management: From Spreadsheets to Standardized Practices
- 1. Transforming Technology Transfer and Recipe Management From Spreadsheets to Standardized Practices Paul Wlodarczyk, VP Solutions Consulting, JustSystems DocTrain Life Sciences 24 June 2008
- 3. Product Life Cycle Process Definition Pilot Scale Early Development Late Development Project Management LIMS / SDMS QMS / CAPA Lab Scale Electronic Lab Notebooks Users Project Operations Scientists Chemists Biologists Pharmacists Engineers Technicians Operators Support Analytical Quality MES ERP PLM Development Management Tech Transfer Clinical I Clinical II Clinical III Commercial Experiments Process Unit Procedures Commercial Scale Source: Mike Power, BearingPoint Product Demand Supply
- 6. “ Master Data”: Coordination Points for Manufacturing include both Product and Process Opportunity to use ISA-88 recipe as the common information model for process definitions? Supply Demand Product Design/Formulation Marketing Collateral Service Docs Data Sync E-Commerce Order Acquisition & Management Supply Chain Planning (mBOM, Routing) Sourcing & Procurement Product Package Design/ Label Claims Recipe Management Detailed Routing Bill of Equipment Bill of Process Bill of Compliance/ CoA Bill of Test Asset Maintenance Bill of Materials Process Specifications Process Engineering Maintenance Plans SOPs Asset Performance Management Opportunity to use ISA-88 recipe as the common information model for process definitions? Opportunity to use ISA-88 recipe as the common information model for process definitions? common information models
- 7. ISA-88 Operations Ice Cream Recipe Example The Blend Ingredients Operation - eight phases associated with blending ingredients. Note there is no rule on running only one phase at a time. In fact, it is very common for multiple phases to be running simultaneously. Recipe represented in an industry standard ISA-88 SFC (sequential function chart)
- 19. The xfy Process Definition Solution BatchML storage of recipes and recipe building blocks ISA-88 Editor for visual editing and navigation of Process Definitions Drawing palettes for ISA-88 shapes and reusable components Double-click on shapes to drill down, add process parameters
- 20. Product Life Cycle Process Definition Pilot Scale Early Development Late Development Project Management LIMS / SDMS QMS / CAPA Lab Scale Electronic Lab Notebooks Users Project Operations Scientists Chemists Biologists Pharmacists Engineers Technicians Operators Support Analytical Quality MES ERP PLM Development Management Tech Transfer Clinical I Clinical II Clinical III Commercial Experiments Process Unit Procedures Commercial Scale Source: Mike Power, BearingPoint Process definition tools facilitate early process development 1 Process definitions refined, tech transfer at every point of scale 2 4 Tech transfer improved through machine-readable BatchML Process definitions transformed into ISA-88 control recipes in MES or Batch Control System 5 Manufacturing knowledge transferred to development through library of reusable process actions 6 ISA-88 recipes used for Description of Manufacturing Process & Process Controls (section 3.2.S.2.2) of CTD. 3