This document summarizes a presentation on improving operations performance through electronic guides (eGuides) in regulated industries. It discusses how traditional manufacturing documentation is often paper-based, including standard operating procedures, work orders, and quality records. An eGuide moves this documentation to a digital system, with contents and documents converted to digital files interconnected in a plant operations model. Implementing an eGuide provides benefits like centralized access to documents, version control, electronic signatures, and improved traceability and reporting. The presentation provides examples of how eGuides can model production processes and guide operators through work orders. It also discusses resources for defining, approving, executing, tracking, and analyzing manufacturing operations using eGuides.
Introduction, Objective; Significance; General consideration; Pilot plant scale up technique for solid, liquid and semi solids; SUPAC Guidelies; Introduction to platform technology
Best Practices in Data Collection for Successful Manufacturing IntelligenceJeffery Cawley
Robust Manufacturing Intelligence (MI) capabilities are fundamental to successful manufacturing enterprise management. And robust MI capabilities start with sound data collection practices.
The analytics feeding management dashboards will work with any properly formed data that can be drawn from manufacturing databases. However, if that data is compromised, the decisions made by management based on the compromised data may be faulty and put the organization at risk.
The key to world-class, sound decision making is a solid data collection foundation. This webinar examines data collection best practices:
• The requirements standards such as ISA 95, FDA Q10, and ISO 9001 and good manufacturing practices place upon the data collection process.
• The business implications of poor data collection.
• What data collection best practices should be implemented:
o Operator workflow support
o SOP enforcement
o Input error reduction
o Data integrity
• How data collection integrates with manufacturing management systems
The end result is compliant process and testing data collection that dependably provides high-quality data to feed the analytics that informs MI. Data collection with integrity is a core requirement to make MI work while keeping auditors and customers satisfied.
Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy
Content :-
Current good manufacturing Practices
Equipment and their maintenance
Production Management
Conclusion
References
Introduction, Objective; Significance; General consideration; Pilot plant scale up technique for solid, liquid and semi solids; SUPAC Guidelies; Introduction to platform technology
Best Practices in Data Collection for Successful Manufacturing IntelligenceJeffery Cawley
Robust Manufacturing Intelligence (MI) capabilities are fundamental to successful manufacturing enterprise management. And robust MI capabilities start with sound data collection practices.
The analytics feeding management dashboards will work with any properly formed data that can be drawn from manufacturing databases. However, if that data is compromised, the decisions made by management based on the compromised data may be faulty and put the organization at risk.
The key to world-class, sound decision making is a solid data collection foundation. This webinar examines data collection best practices:
• The requirements standards such as ISA 95, FDA Q10, and ISO 9001 and good manufacturing practices place upon the data collection process.
• The business implications of poor data collection.
• What data collection best practices should be implemented:
o Operator workflow support
o SOP enforcement
o Input error reduction
o Data integrity
• How data collection integrates with manufacturing management systems
The end result is compliant process and testing data collection that dependably provides high-quality data to feed the analytics that informs MI. Data collection with integrity is a core requirement to make MI work while keeping auditors and customers satisfied.
Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy
Content :-
Current good manufacturing Practices
Equipment and their maintenance
Production Management
Conclusion
References
Good Manufacturing Practices.
Basic rules of GMP
Various aspects of GMP.
How do GMP change.
Comparison of GMP.
Quality assurance
Principles of QA
Functions of QA department.
Documentation
Importance of documentation of records
Important areas of documentation
Components of documentation
Important for D. Pharmacy, B. Pharmacy and M. Pharmacy.
A brief introduction to the basic of pilot plant scale up and its objectives, significance, applications and importance
Pilot Plant Scale Up Techniques Used in Pharmaceutical Manufacturing, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
Introduction to pilot plant and scale up technologyvasantipatil5
This presentation include basic introduction to pilot plant and scale up technology. following points are definition, objective , process evaluation, SUPAC , advantages and dis advantages etc
As the worldwide business climate has grown increasingly complex – due to globalization, consolidation, governmental regulation, labour issues, financial pressures, supply chain management and security concerns – the purview of “operations management” has expanded.
Operations management is the business function that plans, organizes coordinates and controls the resources needed to produce a company’s goods and services.
It is mainly concerned with managing the process that converts inputs into outputs.
It closely interacts with the accounting, finance and human resource management function in an organization.
Pharmacy is a highly competitive industry, and companies are experiencing financial pressures more than ever before.
Hence OPERATIONS MANAGEMENT IS THE CENTRAL CORE FUNCTION OF EVERY COMPANY
Organizing Data to Enable Enterprise-wide Manufacturing IntelligenceNorthwest Analytics
Successful enterprise-wide manufacturing information and analytics systems require a consisten organization of data that can accommodate expansion and changes. Most enterprises end up patching together manufacturing and business databases based on the need of different applications These differences make it difficult to create useful reports, apply effective analytics, and adapt to changing conditions.
This webinar examines how to analyze data structure needs, design them to fit best practices, and produce a robust data structure that supports current and future manufacturing analytics requirements.
Webinar recording at: https://www1.gotomeeting.com/register/964115408
NWA website - http://www.nwasoft.com
Charlie Gifford, President and Chief Manufacturing Consultant
21st Century Manufacturing Solutions LLC
Hailey, ID
Mr. Gifford is an international independent consultant for optimizing manufacturing and supply chain systems. He chairs the ISA-95 Best Practices Working Group which produces public methods for aligning Continuous Improvement and Manufacturing Operations Manufacturing systems to optimize manufacturing work processes. He is the author of four books, most recently, When Worlds Collide in Manufacturing Operations: ISA-95 Best Practices Book 2.0. http://bit.ly/pL2pfN
Good Manufacturing Practices.
Basic rules of GMP
Various aspects of GMP.
How do GMP change.
Comparison of GMP.
Quality assurance
Principles of QA
Functions of QA department.
Documentation
Importance of documentation of records
Important areas of documentation
Components of documentation
Important for D. Pharmacy, B. Pharmacy and M. Pharmacy.
A brief introduction to the basic of pilot plant scale up and its objectives, significance, applications and importance
Pilot Plant Scale Up Techniques Used in Pharmaceutical Manufacturing, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
Introduction to pilot plant and scale up technologyvasantipatil5
This presentation include basic introduction to pilot plant and scale up technology. following points are definition, objective , process evaluation, SUPAC , advantages and dis advantages etc
As the worldwide business climate has grown increasingly complex – due to globalization, consolidation, governmental regulation, labour issues, financial pressures, supply chain management and security concerns – the purview of “operations management” has expanded.
Operations management is the business function that plans, organizes coordinates and controls the resources needed to produce a company’s goods and services.
It is mainly concerned with managing the process that converts inputs into outputs.
It closely interacts with the accounting, finance and human resource management function in an organization.
Pharmacy is a highly competitive industry, and companies are experiencing financial pressures more than ever before.
Hence OPERATIONS MANAGEMENT IS THE CENTRAL CORE FUNCTION OF EVERY COMPANY
Organizing Data to Enable Enterprise-wide Manufacturing IntelligenceNorthwest Analytics
Successful enterprise-wide manufacturing information and analytics systems require a consisten organization of data that can accommodate expansion and changes. Most enterprises end up patching together manufacturing and business databases based on the need of different applications These differences make it difficult to create useful reports, apply effective analytics, and adapt to changing conditions.
This webinar examines how to analyze data structure needs, design them to fit best practices, and produce a robust data structure that supports current and future manufacturing analytics requirements.
Webinar recording at: https://www1.gotomeeting.com/register/964115408
NWA website - http://www.nwasoft.com
Charlie Gifford, President and Chief Manufacturing Consultant
21st Century Manufacturing Solutions LLC
Hailey, ID
Mr. Gifford is an international independent consultant for optimizing manufacturing and supply chain systems. He chairs the ISA-95 Best Practices Working Group which produces public methods for aligning Continuous Improvement and Manufacturing Operations Manufacturing systems to optimize manufacturing work processes. He is the author of four books, most recently, When Worlds Collide in Manufacturing Operations: ISA-95 Best Practices Book 2.0. http://bit.ly/pL2pfN
ARC's Sal Spada Packaging Machinery Presentation @ ARC Industry Forum 2010ARC Advisory Group
ARC's Sal Spada Packaging Machinery Presentation @ ARC Industry Forum 2010 in Orlando, FL.
Latest Developments in Packaging Machinery
Trends in Packaging Line Configurations
♦Overall production operation can be balanced
with a combination of high speed mechatronic
packaging lines in combination with rapid
changeover robotic packing lines.
♦Operational strategy going forward does not
mean that robotics will displace specialized
packaging machinery such as blister, flow
wrappers, or form/fill/seal packing machinery.
♦Going forward, the industry challenge is to
determine the optimal combination of rapid
changeover, but slower robotic lines that create a
balance with dedicated high speed lines.
Danone-a practitioner approach to packaging line productivity by Mathieu Lora...Monique Watkins
Mat shares Unique Strategies for Improving Packaging Line Productivity. You don't want to miss this. Recorded webinar can be found at http://www.plantseminars.com
Industry 4.0 - Enabling operational excellence of packaging linesStephane Potier
Industry 4.0 is a revolution in operational excellence for smart factories. Packaging industry experts weigh in on current trends and share their visions for the future.
The Future Foundation has carried out an extensive forecasting exercise to explore the future of several commercial themes and sectors beyond 2020. In this report, we examine our predictions for the future of retail, identifying informed assumptions for the evolution of consumer trends, product and service innovations and the role that technological developments will play. We also provide invented images of retail concepts that might characterize the future marketplace as a result of the shifts we describe.
This PDF describes demo of GMP documents kit which are primary documentation requirements. This document is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.
This document has been prepared to provide a summary on the changes between ISO 13485:2003 and ISO 13485:2016. The documents contains the following:
a. Benefits of the new version of the standard.
b. Few key definitions
c. Mapping between the versions as per ISO.org.
d. Summary of key changes between the versions of the standard
In this presentation, we will discuss production planning system, factors determining production control procedure, role of production planning and control in operations management, scope of production planning and control, its phases and principles. We will also talk about framework for strategy formulations and task control, PPC limitations, effectiveness, PPC in different systems, requirement of an effective PPC in a system and make or buy analysis.
To know more about Welingkar School’s Distance Learning Program and courses offered, visit: http://www.welingkaronline.org/distance-learning/online-mba.html
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...Merck Life Sciences
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 ...MilliporeSigma
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
VirGo eSOP offers Digitalization of SOPs. It offers improved efficiency, fewer errors, higher throughput, better visibility, better quality and higher operatorr efficiency!
Simplified Documentation
Companies have to maintain large no of documents for compliance. Records are essential for demonstrating that product meets designated quality standards.
With VirGo digital SOPs you can document each step of a process. User data provides a record of the individual who executed the process, and a step-based application format provides a time marker for every step completion.
All of the information can be store in excel sheets and is easily accessible when needed. These records can be exported to create a batch record report and, when combined with electronic logbooks, provide a record of process execution and validation.
Standardization of Procedures Reduces Risk
Paper-based instructions create the opportunity for variation. Even the best-written, clearest SOPs leave a window for individual interpretations. In highly regulated industries, these individual variations are a significant source of risk.
Digital SOPs remove the chance of variation. These SOPs guarantee that workers are performing every step as specified. If errors do occur, in-app error reports let workers document the problem accurately, at the source.
Controlled Permissions
A common concern is that an end-user might accidentally change a critical setting. In a validated facility, such changes could have unintended, potentially severe consequences.
VirGo digital SOPs tightly control which users have access to which feature. For example, the engineers creating SOPs on VirGo will have the ability to author and edit SOPs0. If necessary, the highest level of control can be reserved for IT, who are responsible for integrating and administering the platform. The admins can limit end-users power in the platform to running SOPs in production contexts.
This ensures that digital systems are safe, compliant, and suited to local needs
Better Quality with In Line Reporting
Mistakes and non-conformances will inevitably happen. While it’s important to prevent them, it’s just as important that they’re documented correctly.
VirGo Digital SOPs let operators report errors in line. Engineers can create custom error report forms for each process, enabling workers to provide the necessary information
Data Integrity by Design
Currently, documentation is a paper-based, manual process.
Documenting processes by hand is inefficient, and doing so by hand increases the likelihood of error, illegible entries, or misfiling forms.
VirGo SOP creation tool ensures that data meets the rigorous standards outlined in regulations. It is protected at workstations, in the cloud, or in your on-premise servers, as well as in transit.
Vegam Solutions Pte Ltd offers software solutions to Manufacturing Plants. Offers IIOT and Execution systems integrated with ERP and other IT solutions.
This publication is about HACCP documentation kit that describes list of various documents which cover requirements of HACCP Documentation. HACCP is a tool to assess hazards and establish control systems that focus on prevention
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPadMilliporeSigma
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)
Smart Data Management and Advanced Analytics with Bio4C™ ProcessPadMerck Life Sciences
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)
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...Merck Life Sciences
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
Communications Mining Series - Zero to Hero - Session 1DianaGray10
This session provides introduction to UiPath Communication Mining, importance and platform overview. You will acquire a good understand of the phases in Communication Mining as we go over the platform with you. Topics covered:
• Communication Mining Overview
• Why is it important?
• How can it help today’s business and the benefits
• Phases in Communication Mining
• Demo on Platform overview
• Q/A
Securing your Kubernetes cluster_ a step-by-step guide to success !KatiaHIMEUR1
Today, after several years of existence, an extremely active community and an ultra-dynamic ecosystem, Kubernetes has established itself as the de facto standard in container orchestration. Thanks to a wide range of managed services, it has never been so easy to set up a ready-to-use Kubernetes cluster.
However, this ease of use means that the subject of security in Kubernetes is often left for later, or even neglected. This exposes companies to significant risks.
In this talk, I'll show you step-by-step how to secure your Kubernetes cluster for greater peace of mind and reliability.
Alt. GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using ...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Threats to mobile devices are more prevalent and increasing in scope and complexity. Users of mobile devices desire to take full advantage of the features
available on those devices, but many of the features provide convenience and capability but sacrifice security. This best practices guide outlines steps the users can take to better protect personal devices and information.
Why You Should Replace Windows 11 with Nitrux Linux 3.5.0 for enhanced perfor...SOFTTECHHUB
The choice of an operating system plays a pivotal role in shaping our computing experience. For decades, Microsoft's Windows has dominated the market, offering a familiar and widely adopted platform for personal and professional use. However, as technological advancements continue to push the boundaries of innovation, alternative operating systems have emerged, challenging the status quo and offering users a fresh perspective on computing.
One such alternative that has garnered significant attention and acclaim is Nitrux Linux 3.5.0, a sleek, powerful, and user-friendly Linux distribution that promises to redefine the way we interact with our devices. With its focus on performance, security, and customization, Nitrux Linux presents a compelling case for those seeking to break free from the constraints of proprietary software and embrace the freedom and flexibility of open-source computing.
LF Energy Webinar: Electrical Grid Modelling and Simulation Through PowSyBl -...DanBrown980551
Do you want to learn how to model and simulate an electrical network from scratch in under an hour?
Then welcome to this PowSyBl workshop, hosted by Rte, the French Transmission System Operator (TSO)!
During the webinar, you will discover the PowSyBl ecosystem as well as handle and study an electrical network through an interactive Python notebook.
PowSyBl is an open source project hosted by LF Energy, which offers a comprehensive set of features for electrical grid modelling and simulation. Among other advanced features, PowSyBl provides:
- A fully editable and extendable library for grid component modelling;
- Visualization tools to display your network;
- Grid simulation tools, such as power flows, security analyses (with or without remedial actions) and sensitivity analyses;
The framework is mostly written in Java, with a Python binding so that Python developers can access PowSyBl functionalities as well.
What you will learn during the webinar:
- For beginners: discover PowSyBl's functionalities through a quick general presentation and the notebook, without needing any expert coding skills;
- For advanced developers: master the skills to efficiently apply PowSyBl functionalities to your real-world scenarios.
Elevating Tactical DDD Patterns Through Object CalisthenicsDorra BARTAGUIZ
After immersing yourself in the blue book and its red counterpart, attending DDD-focused conferences, and applying tactical patterns, you're left with a crucial question: How do I ensure my design is effective? Tactical patterns within Domain-Driven Design (DDD) serve as guiding principles for creating clear and manageable domain models. However, achieving success with these patterns requires additional guidance. Interestingly, we've observed that a set of constraints initially designed for training purposes remarkably aligns with effective pattern implementation, offering a more ‘mechanical’ approach. Let's explore together how Object Calisthenics can elevate the design of your tactical DDD patterns, offering concrete help for those venturing into DDD for the first time!
Sudheer Mechineni, Head of Application Frameworks, Standard Chartered Bank
Discover how Standard Chartered Bank harnessed the power of Neo4j to transform complex data access challenges into a dynamic, scalable graph database solution. This keynote will cover their journey from initial adoption to deploying a fully automated, enterprise-grade causal cluster, highlighting key strategies for modelling organisational changes and ensuring robust disaster recovery. Learn how these innovations have not only enhanced Standard Chartered Bank’s data infrastructure but also positioned them as pioneers in the banking sector’s adoption of graph technology.
Essentials of Automations: The Art of Triggers and Actions in FMESafe Software
In this second installment of our Essentials of Automations webinar series, we’ll explore the landscape of triggers and actions, guiding you through the nuances of authoring and adapting workspaces for seamless automations. Gain an understanding of the full spectrum of triggers and actions available in FME, empowering you to enhance your workspaces for efficient automation.
We’ll kick things off by showcasing the most commonly used event-based triggers, introducing you to various automation workflows like manual triggers, schedules, directory watchers, and more. Plus, see how these elements play out in real scenarios.
Whether you’re tweaking your current setup or building from the ground up, this session will arm you with the tools and insights needed to transform your FME usage into a powerhouse of productivity. Join us to discover effective strategies that simplify complex processes, enhancing your productivity and transforming your data management practices with FME. Let’s turn complexity into clarity and make your workspaces work wonders!
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. What’s changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
Climate Impact of Software Testing at Nordic Testing DaysKari Kakkonen
My slides at Nordic Testing Days 6.6.2024
Climate impact / sustainability of software testing discussed on the talk. ICT and testing must carry their part of global responsibility to help with the climat warming. We can minimize the carbon footprint but we can also have a carbon handprint, a positive impact on the climate. Quality characteristics can be added with sustainability, and then measured continuously. Test environments can be used less, and in smaller scale and on demand. Test techniques can be used in optimizing or minimizing number of tests. Test automation can be used to speed up testing.
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...
The eManufacturing Guide v.1.0
1. www.mesa.org2010 European Conference Unlocking Your Operations Potential
November 9-10, Düsseldorf, Germany
Improving operations
performance through eGuides
in regulated industry
David Badia
Principal consultant & CEO
2. 2
The following Strategic Initiatives of
MESA International are associated with
this presentation:
Lean Manufacturing
Quality & Regulatory Compliance
Real-Time Enterprise
3. 3
1. Traditional manufacturing operative in question
2. Common Manufacturing Guide context
3. Implementation of a Manufacturing eGuide
4. Resources to use & how to make MeG real.
5. Almirall’s way to operations excellence
6. Continuous improvement …
7. Questions & answers.
Improving operations
performance through eGuides
4. 4
Processes and Operations in the pharmaceutical plants:
– Specialized preparation of materials: weight and dispense
• Order and recipe management systems.
– Complex production processes: formulation
• advanced instrumentation, control and analytical technology.
• batch control systems.
– High integrated conditioning and packaging lines
• Supervisory, inspection and statistical quality control systems
Capacity & reliability specialization & automation
Traditional Manufacturing
operative in question
5. 5
Processes and Operations in the pharmaceutical plants:
– Production modules: granulation, mixing, drying, compression,
coating, ...
– Conditioning and packaging modules: filling, blistering, cartoning,
packing, …
– Manual activities: cleaning, sample collection, in-process quality
control, format changes, equipment setup, visual inspections, …
flexibility & productivity manual supervision using paper !!
Traditional Manufacturing
operative in question
6. 6
Typical documentation which remains on paper:
– Product related: recipes, bills of material and material safety data.
– Job related: standard operation procedures, work order.
– Asset related: operating instructions and “set-up” specifications.
… but also:
– Reports for production release and certification.
– In-process control forms.
– Sample collection forms for analytical quality control.
– Logbooks of other daily activities.
– Operation yield control records.
– Annotations of exceptions, deviations and failures.
Traditional Manufacturing
operative in question
7. 7
1. Traditional manufacturing operative in question
2. Common manufacturing guide context
3. Implementation of a Manufacturing eGuide
4. Resources to use & how to make MeG real.
5. Almirall’s way to operations excellence
6. Continuous improvement …
7. Questions & answers.
Improving operations
performance through eGuides
8. 8
•Production and conditioning of
pharmaceutical solid dose products:
•Production:
•Granulator module,
•Blender module,
•Tableting machine,
•Coating machine.
•Conditioning:
•Blister line,
•Cartoner machine and
•Case packer.
Manufacturing operations guide applied to:
Common Manufacturing Guide
context
10. 10
Weighed RM
in a BIN
Empty
containers
Weighed RM
in a box
Intermediate
prod. containers
W&D
Report
Box
roadmap
BIN
roadmap
Module
SOP
Module
Logbook
Manufact.
Guide
Machine
Specs.
In-Process
Control
Selección de evacuación posterior de Palet M.P. en SAS
Comprobar Condiciones
de Manipulación
Inicio Pesada
Etiquetado y Tarado de
envase
Tarado del BIN
Recepción BIN
Lectura de Bultos y
Pesada de Materia Prima
Recepción y Validación de
la Paleta
Aceptación de la Pesada
Introducción de Materia
Prima pesada en el BIN
Evacuación de la paleta y comprobación peso SAS
Llenado de paleta
vacía con bultos pesados
Limpieza de componente
BIN (1ª Pesada)
Resto pesadas BIN
Armario o
Pesada pico
BIN
Pesada en BINPesada en Envase
Báscula 2, Pesada no aceptada
BIN y Pesada en Envase
A partir de la segunda pesada de
la misma paleta
Primera pesada,
cambio de
paleta o
reanudación
Quedan
pesadas
por
realizar
Según procedimiento
Identificación de Bulto
Pesado
Synoptic
graphs
Material
Safety Data
Scale
SOP
Production
Report
Samples to
laboratoryQA
Analysis
Lot preparation at production
module level
11. 11
Documents used or generated in the production module:
1. Weight and dispense order report,
2. Material in box container roadmap,
3. Material in BIN container roadmap,
4. Module room cleaning Standard Operating Procedure (SOP),
5. Module tasks logbook,
6. Guide of operations of manufacturing workorder in the module,
7. Set-up, configuration and cleaning SOP for equipment and
tools.
8. Synoptic graphs of equipment and accessories.
9. Material safety data specifications,
10. Test of samples for in-process control SOP,
11. Scale standardization and operation instructions,
12. Sample collection for analysis in QA laboratory and for
mandatory storage of lot samples.
Information at production
module level
12. 12
1. Traditional manufacturing operative in question
2. Common manufacturing guide context
3. Implementation of a Manufacturing eGuide
4. Resources to use & how to make MeG real.
5. Almirall’s way to operations excellence
6. Continuous improvement …
7. Questions & answers.
Improving operations
performance through eGuides
13. 13
The “electronic” guide of Manufacturing
operations is based on moving from the
shape of the “traditional” manufacturing
guide of a product or recipe on paper,
to an interactive information technology
system with the conversion of contents and
documents in digital data and files,
interrelated in a plant operations model.
+
MeG
Implementation of a
Manufacturing eGuide
14. 14
+ Added value:
• Verification of manual data entry for reliability,
• Centralized access to documents related to MeG,
• Secure access to functions and assets,
• Lifecycle management of eGuides with version
control from edition to approval,
• Electronic signature to certify critical operations,
• Historical data log records protected,
• Audit trail of data changes in regulatory records,
• Advanced reporting of genealogy and traceability.
MeG
Implementation of a
Manufacturing eGuide
15. 15
1. Traditional manufacturing operative in question
2. Common manufacturing guide context
3. Implementation of a Manufacturing eGuide
4. Resources to use & how to make MeG real.
5. Almirall’s way to operations excellence
6. Continuous improvement …
7. Questions & answers.
Improving operations
performance through eGuides
16. 16
1. Definition and approval of a eGuide.
2. Plan and assign a Guide to a work
order for a product or recipe.
3. Execute the operations of work
order.
4. Track and analyze the activity and
results.
Audit the manufacturing process.
The fundamental process of the manufacturing guides is:
1
2
3
4
Resources to use & how to
make MeG real.
17. 17
• Step by step definition of operator actions inside
the eGuide.
• Modeling of production processes and routes of
the plant.
• Specific instructions for any process,
product/recipe and manufacturing route.
• Assignment of standard steps and actions to
define each operation behavior:
• Instructions and check-lists,
• Operator confirmation of execution,
• Operators single or multiple electronic signatures,
• Manual data entry,
• Process attributes or parameters registration.
eGuide & Recipe
Management
Definition and approval of a
eGuide
19. 19
• Work Order creation for product or recipe
assigning an approved eGuide.
• Work Order release assigning a route of a
specific line or process.
• Tracking the status of current orders and
operations.
• Order management to change priorities,
suspend, release, sequence, close or cancel.
WORK ORDER
SCHEDULING
Plan and assign a Guide to a
work order
20. 20
• Operations execution and steps data entry.
• Record lot of items/materials consummed and
produced in the operation based on bill of material.
• Record of process events and exceptions.
• In-Process Control data entry for process
statistical analysis and product quality control.
• Display required SOP documents. Access to
additional files in folders during execution.
• Critical operations certification including
electronic signature.
PRODUCTION &
CONDITIONING
OPERATOR
Execute the operations of
work order.
21. 21
Supervisor
Conditioning process
Operation 100
Blistering
Operation 200
Cartoning
Operation 300
Packing
Operator
Work Order WO - 1
Operation 100
Blistering
ready
Operation 200
Cartoning
pending
Operation 300
Packing
pending
WO-1
Blistering
running
Blistering
completed
Cartoning
ready
Cartoning
running
Cartoning
completed
Packing
ready
Plant operations modelling in
the MeG, an example
23. 23
• Support during execution of manufacturing
orders.
• Manufacturing order tracking.
• Review of Production data and results.
• Verification and acceptance of incidences.
• eGuide final report approval.
• Order release to next process.
PRODUCTION
SUPERVISION
Track and analyze the activity
and results
24. 24
1. Traditional manufacturing operative in question
2. Common manufacturing guide context
3. Implementation of a Manufacturing eGuide
4. Resources to use & how to make MeG real?
5. Almirall’s way to operations excellence
6. Continuous improvement …
7. Questions & answers.
Improving operations
performance through eGuides
26. 26
Almirall’s centres
Headquarters:
R&D Centers:
Chemical plants:
Pharmaceutical
plants:
Affiliates:
• Barcelona
• Sant Feliu de Llobregat
• Bad Homburg (Germany)
• Reinbek (Germany)
• Chemical Synthesis Unit in
Sant Just Desvern
• Active Ingredient Scaling-up Unit in
Sant Andreu de la Barca
• Sant Andreu de la Barca
• Sant Celoni
• Sant Andreu de la Barca
• Sant Just Desvern
• Reinbek (Germany)
• Austria, Belgium, France, Germany,
Italy, Mexico, Poland, Portugal, Spain,
Switzerland and the United Kingdom-
Ireland.
27. 27
Almirall’s figures
• 239 pharmaceutical
specialties (*)
• 543 presentations (*)
• 57 countries
• 89.3 million units of
finished product
• 3.5 million units in bulk
(**) Third parties included
28. 28
Scope of implementation in
Sant Andreu plant
• 3 QC/Sampling cabins
• 5 Weigh&Dispense cabins
• 3 Liquid formulation modules
• 3 Solid formulation modules
• 6 Doses production modules
29. 29
Recipe Edition and
Management
• Weigh, formulation and
dispensing recipe edition.
• Paperless manufacturing guide
implementation.
• General Unit Procedure.
• Bill of Equipment (BOE).
• Use of action list with steps
– Instructions with check-in lists.
– Signatures (initial, single, double)
– eDocuments: Standard operation
procedures (SOP), material safety
data sheets (MSDS), process
synoptic graphs and other specs.
• Recipe review and approval cycle.
30. 30
Manufacturing Orders
Scheduling
• Orders are released from the ERP
based on plant capacity.
• Automatic generation of mfgt.
orders in the POMS MES system.
• Batch generation for weight, liquid
formulation, solid formulation and
solid dosing operations.
• Assignment of related process
unit.
• Exception monitoring.
• Procedure traceability.
31. 31
Solids Formulation Operation
• 2 formulation lines: dryer line and
mixer line.
• Combined or separated operation.
• Manufacturing eGuide by actions
• Check-in process unit and assets.
• Registration of raw material and
WIP containers.
• Minor raw materials preparation in
auxiliary tank.
• Cleaning control of cabin &
assets.
• Automated BIN movement control.
• Formulation batch report.
32. 32
Solids Dosing Operation
• 6 dosing lines: tablets, capsules
and sachets.
• Manufacturing eGuide with
process synoptic and product
specs.
• Check-in process unit and assets.
• Registration of conditioning
material and empty drum carriers.
• Units registration of bags and
drums with barcode labels.
• Control of dose weigh.
• Waste reporting and mass yield
calculation of batch.
• Dosing batch report.
33. 33
Production supervision
• Support during execution of
manufacturing orders.
• Exception management.
• Review of Production reports.
• Verification and acceptance of
incidences.
• Production report approval.
• Order / Batch release to next step.
34. 34
• Technological infrastructure update
(equipment, hardware & software)
• Standard life sciences MES
package but customizations
required
• Logistics System integration.
• Minimal interferences with plant
production planning.
• System Qualification and Validation
for regulatory compliance.
• External plant personnel.
• Communication with legacy
equipments, systems and
installations.
• International supplier with a
recently new local integrator.
• Standardization and
homogenization of the system
among the processes.
• Project scope spitted in 3 phases
for shorter milestones, visible
results:
(1º) QC / Sampling,
(2º) Weigh & Dispense,
(3º) Formulation and Dosing.
• Specialized consultancy:
intensive work vs constant work,
consultancy costs vs training costs.
• Evaluation of the real effort with an
assumable planning for everybody.
• Creation of a multidisciplinary
human team for the project.
• Certified technical training and
practical learning by doing.
• Analysis of requirements in depth.
• Realignment with the standard
MES product functionality to reduce
customizations.
Challenges and solutions
35. 35
1. Traditional manufacturing operative in question
2. Common manufacturing guide context
3. Implementation of a Manufacturing eGuide
4. Who & how make MeG real?
5. Almirall’s way to operations excellence
6. Continuous improvement …
7. Questions & answers.
Improving operations
performance through eGuides
36. 36
• for the definition:
• Assets specifications, set-up instructions and parametrization.
• Shopfloor devices & equipment interface (for automated plant
data collection, conection to field instrumentation, etc.).
• for scheduling:
• ERP system interface of work order, inventory, reporting material
quantities of production, consumption and scrapts.
• for execution:
• Data entry of production, consumption and scrapts of material.
• Asset set-up based on specifications.
• Automated plant data collection for step action and data logging.
• for analysis:
• Raw material lot traceability during operations (work in process).
• Product genealogy, Inventory reports, Work order event logs.
• Audit trail reporting.
Continuous improvement ...
enhanced functionality
37. 37
• Common model and services available
• Modular and scalable system’s architecture
Using
• Dynamic order priority and route sequencing
• Human resources tasks management
• Shopfloor interface to equipment and HMI.
Using
• Real time inventory management
• Definition of materials, substitutes y secondary prod.
• Bill of Material (BOM)
Using
• Manufacturing centralized model
• Implementation of Standard Operational Procedures
• Certification of critical events
Using
• Current Work Order in process management
• Production events recording
Using
Current production vs. plan
compliance
Process and production
consistency improvement
Inventory performance
improvement
Order “Lead Time”
reduction
Using an incremental
approach to the operational
improvement
Continuous improvement ...
bigger scope
38. 38
• ANSI/ISA-95: Enterprise-Control System Integration.
• GAMP5: Good Automated Manufacturing Practice. Guide
for Validation of Automated System.
• CFR Title 21 FDA Part 11 – Electronic Records; Electronic
Signatures (USA CFR regulation).
• Guidance for Industry Parte 11, Electronic Records;
Electronic Signatures – Scope and Application
(August 2003).
• Risk Based Approach to Compliant Electronic
Records and Signatures (ISPE, October 2005).
Continuous improvement ...
regulatory compliance
39. 39
The manufacturing operations eGuide
is a key to success of plant continuous
improvement strategies,
helping in the daily tasks of all human
resources responsible for manufacturing,
sharing essential information
across plant areas and
enabling regulatory compliance.
The IT “facilitator” of plant
human resources
MeG
40. 40
1. Traditional manufacturing operative in question
2. Common manufacturing guide context
3. Implementation of a Manufacturing eGuide
4. Who & how make MeG real?
5. Continuous improvement …
6. Almirall’s way to operations excellence
7. Questions & answers.
Improving operations
performance through eGuides
Esto es un ejemplo del concepto de gestión de Orden de FabricaciónLas ordenes se crean manualmente o mediante el interfase ERP para un proceso y una guía (producto) por parte del usuario Supervisor que puede gestionar la liberación y el avance durante la ejecución de las mismas.Las ordenes se descomponen en subordenes que ejecutan en una o múltiples operaciones a través de la estación de operación por parte del usuario Operador.
Esto es un ejemplo del concepto de gestión de Orden de FabricaciónLas ordenes se crean manualmente o mediante el interfase ERP para un proceso y una guía (producto) por parte del usuario Supervisor que puede gestionar la liberación y el avance durante la ejecución de las mismas.Las ordenes se descomponen en subordenes que ejecutan en una o múltiples operaciones a través de la estación de operación por parte del usuario Operador.
Esto es un ejemplo del concepto de gestión de Orden de FabricaciónLas ordenes se crean manualmente o mediante el interfase ERP para un proceso y una guía (producto) por parte del usuario Supervisor que puede gestionar la liberación y el avance durante la ejecución de las mismas.Las ordenes se descomponen en subordenes que ejecutan en una o múltiples operaciones a través de la estación de operación por parte del usuario Operador.
El Sistema de Guía de Fabricación tiene las siguientes posibilidades: - Planificación, priorizar, ejecutar Órdenes de Trabajo - Registro de eventos tales como consumo, producción de materiales, iniciar, detener las órdenes, etc - Modelo de producción es la base: entidades y sus relaciones - Normas de producción puede ser definidos en vigor durante la producción: el orden de las operaciones y las medidas - Los certificados se pueden aplicar en la parte de la Orden de ejecución por medio de permisos a las personas que actúen en el proceso de fabricación. Por ejemplo: el permiso para aprobar las muestras de análisis de laboratorio, el permiso de conducir una carretilla elevadora - Registro del inventario de la producción real se puede hacer. Los movimientos de materiales se registran, los eventos y las cantidades en el inventario se actualizan automáticamente. - Definición de los procesos de producción, los materiales que se utilicen y produzcan - Planificación y programación de los trabajos de producción - La gestión de trabajo: los costos? - La conectividad a la planta a través del conector de fábrica y al SAP a través del conector ERP- Software escalable, con la posibilidad de poner en práctica paso a paso la nueva funcionalidad, como la genealogía de producto.