IT’S TIME FOR POWERFUL NEW SOLUTIONS IN MEDICAL
DEVICE LABELING. For medical device manufacturers, labeling is growing in importance, and there are a number of reasons why.
Enterprise Labeling for the Pharmaceutical IndustryLoftware
For the pharmaceutical industry, the focus is on patient safety and improved patient outcomes. It’s also on driving greater efficiencies, cost reductions, and collaboration with contract manufacturers throughout the supply chain. In this environment, labeling is growing in importance, and there are a number of reasons why.
Developing And Executing A Program For Labeling ComplianceChris Miller
The document discusses developing a program for labeling compliance. It notes that labeling has become complex due to increasing regulations from various government bodies. An ideal solution would be one that adapts to regulatory changes and lowers risks of non-compliance. Key aspects of implementing a solution include user training, validation, label design, documentation, and supplier management. The document provides an overview of developing a holistic labeling compliance program.
Medical device companies struggle with CAPA compliance due to fragmented and manual systems. An effective CAPA system requires planning, integrated data sources, risk-based prioritization of issues, and trend analysis. It also needs employee training and management processes to monitor performance and drive accountability. A comprehensive electronic CAPA management system can help companies achieve compliance by connecting people, procedures, and data across the organization.
This document discusses issues with CAPA (Corrective and Preventive Action) programs and best practices for improvement. It notes that CAPA continues to be a top citation for pharmaceutical companies. It recommends taking a holistic approach to CAPA, with planning, source error tracking across the product lifecycle into a sole database, trend analysis integrated with risk management, and employee training and accountability. With these improvements, companies can better identify and address quality issues.
RedLotus is a pharma technical services company that provides consulting services to help pharmaceutical companies achieve and maintain GMP compliance. It has experts with regulatory and manufacturing experience who can assist companies at various stages, from facility design and process validation to responding to regulatory issues. RedLotus' services include quality audits, regulatory inspections preparation, qualification and validation activities, and training. The company aims to help clients develop robust quality systems and avoid compliance problems.
Why validation matters: A Brief Guide to a Critical Aspect of the Pharmaceut...Barry Peters
Validation is a critical process in the pharmaceutical manufacturing lifecycle to ensure quality and safety. It involves proving all aspects of manufacturing and distribution that impact quality, from facilities and equipment to software and risk management. The FDA provides recommendations for validation at all stages and inspects manufacturers' processes. Validation demonstrates processes are capable of consistently producing quality products. It is a legal requirement and important for reducing recalls, lawsuits, and investigations. Thorough documentation is needed to show validation was properly carried out across the entire product lifecycle.
The document discusses the need for medical device manufacturers to comply with ISO 13485:2003 quality standards. It notes that situations like Medtronic paying $268 million to settle lawsuits over faulty defibrillator leads emphasize the importance of standards to ensure quality and manage risk. ISO 13485:2003 provides requirements for a quality management system to consistently meet customer and regulatory requirements. It shifts the focus from end-of-production quality inspection to quality control throughout the production process. Following the standard helps manufacturers realize better quality, cost-effectiveness and time to market for their medical devices.
Product Complaints: Complaint Handling from Intake to ClosureGRCTS
Overview :
An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Complaint handling is no easy task. Management might overlook the importance of customer feedback and be unable to capture all complaints coming from disparate sources. Plus, the additional regulatory reporting requirement related to adverse events may seem overly burdensome to device makers in particular. A strategic risk-based methodology can help streamline the complaint-handling process in medical device manufacturing.
Enterprise Labeling for the Pharmaceutical IndustryLoftware
For the pharmaceutical industry, the focus is on patient safety and improved patient outcomes. It’s also on driving greater efficiencies, cost reductions, and collaboration with contract manufacturers throughout the supply chain. In this environment, labeling is growing in importance, and there are a number of reasons why.
Developing And Executing A Program For Labeling ComplianceChris Miller
The document discusses developing a program for labeling compliance. It notes that labeling has become complex due to increasing regulations from various government bodies. An ideal solution would be one that adapts to regulatory changes and lowers risks of non-compliance. Key aspects of implementing a solution include user training, validation, label design, documentation, and supplier management. The document provides an overview of developing a holistic labeling compliance program.
Medical device companies struggle with CAPA compliance due to fragmented and manual systems. An effective CAPA system requires planning, integrated data sources, risk-based prioritization of issues, and trend analysis. It also needs employee training and management processes to monitor performance and drive accountability. A comprehensive electronic CAPA management system can help companies achieve compliance by connecting people, procedures, and data across the organization.
This document discusses issues with CAPA (Corrective and Preventive Action) programs and best practices for improvement. It notes that CAPA continues to be a top citation for pharmaceutical companies. It recommends taking a holistic approach to CAPA, with planning, source error tracking across the product lifecycle into a sole database, trend analysis integrated with risk management, and employee training and accountability. With these improvements, companies can better identify and address quality issues.
RedLotus is a pharma technical services company that provides consulting services to help pharmaceutical companies achieve and maintain GMP compliance. It has experts with regulatory and manufacturing experience who can assist companies at various stages, from facility design and process validation to responding to regulatory issues. RedLotus' services include quality audits, regulatory inspections preparation, qualification and validation activities, and training. The company aims to help clients develop robust quality systems and avoid compliance problems.
Why validation matters: A Brief Guide to a Critical Aspect of the Pharmaceut...Barry Peters
Validation is a critical process in the pharmaceutical manufacturing lifecycle to ensure quality and safety. It involves proving all aspects of manufacturing and distribution that impact quality, from facilities and equipment to software and risk management. The FDA provides recommendations for validation at all stages and inspects manufacturers' processes. Validation demonstrates processes are capable of consistently producing quality products. It is a legal requirement and important for reducing recalls, lawsuits, and investigations. Thorough documentation is needed to show validation was properly carried out across the entire product lifecycle.
The document discusses the need for medical device manufacturers to comply with ISO 13485:2003 quality standards. It notes that situations like Medtronic paying $268 million to settle lawsuits over faulty defibrillator leads emphasize the importance of standards to ensure quality and manage risk. ISO 13485:2003 provides requirements for a quality management system to consistently meet customer and regulatory requirements. It shifts the focus from end-of-production quality inspection to quality control throughout the production process. Following the standard helps manufacturers realize better quality, cost-effectiveness and time to market for their medical devices.
Product Complaints: Complaint Handling from Intake to ClosureGRCTS
Overview :
An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Complaint handling is no easy task. Management might overlook the importance of customer feedback and be unable to capture all complaints coming from disparate sources. Plus, the additional regulatory reporting requirement related to adverse events may seem overly burdensome to device makers in particular. A strategic risk-based methodology can help streamline the complaint-handling process in medical device manufacturing.
1) IDMP and RIM aim to harmonize product and regulatory information management but face challenges due to conflicting data sources and definitions between organizations and regions.
2) Implementing IDMP requires mapping diverse internal data systems and formats to a common IDMP data model and identifiers, which is complicated by varying data quality, timeliness, and ownership.
3) A master data management approach is needed to define authoritative sources, ownership, validation requirements, and change control to accurately populate the IDMP data containers and address issues across multiple systems over time.
Is your company ready to meet today’s challenges?Lidia Gasparotto
Visit us online at:
www.ibm.com/electronics/medicaldevices
Is your company ready to meet today’s challenges?
Ask yourself the following questions:
Are your products linked to clinical information systems? •
Is your supply chain optimized to track inventory, handle complaints and •
recalls and manage assets?
Can you comply efficiently with divergent security and privacy regula- •
tions?
Does your company get new products to market as quickly as your •
competitors?
Are your operations efficient and profitable? •
Does your company’s IT environment facilitate the formation of strategic •
alliances with insurance companies, HMOs, hospital buying groups and
supply chain logistics companies?
Can you reduce your tax liabilities through the use of commissionaires?
IBM has developed and refined the tools you need.
The document discusses the challenges faced by contract formulation laboratories in meeting increasing demands from pharmaceutical companies to rapidly develop new drugs while maintaining high quality and regulatory compliance standards. It outlines some of the key pressures contract labs face, including tight timelines, changing regulations, and managing resources effectively. It then provides an example of a university-affiliated contract lab, CUPSI, that enforces strict GMP training and procedures for students. The document concludes that as demands increase, contract labs need integrated quality management systems to streamline documentation, improve compliance, and reduce costs and risks.
This document discusses five steps for ensuring regulatory compliance when outsourcing business functions in highly regulated industries. It begins by explaining how strict regulations in industries like pharmaceuticals and food production present challenges for outsourcing. It then provides five steps companies can take to help outsourcing providers maintain compliance: 1) establish regulatory frameworks, 2) develop well-trained teams, 3) deploy knowledge retention strategies, 4) create a compliant workplace culture, and 5) maintain accountable processes. The document concludes with a case study of how one company improved regulatory compliance and reduced staff turnover by outsourcing certain functions.
Batch Manufacturers Require More Robust, Dock-to-Dock Control SystemsARC Advisory Group
Aware of the many choices in products and services, the consumer is conscious
of product price to value and demanding increased product quality,
safety, variety, and convenience. Most industries with batch manufacturing
processes are consolidating, requiring fewer plants to produce an
increased variety of products.
To survive, businesses that employ batch control processes must maximize
return on their assets while satisfying constantly changing consumer demands.
New government regulations continue to increase business costs.
Business and manufacturing process automation and integration have become
critical to business success.
While the functionality and standardization of commercial
off-the-shelf batch control systems has
increased dramatically in the last few years, they still
lack functionality needed to meet current and future
business requirements in the fine chemical, pharmaceutical,
food, and beverage industries. Standards
have been rapidly evolving and suppliers continue to
increase functionality needed to meet user business
requirements. Manufacturers in these industries can now develop an
automation strategy to meet current and future business needs using standard
products based on standards and not limited by technology.
Impax provides concise summaries of forward-looking statements and highlights its focus on four key areas:
1) Continued focus on quality to resolve regulatory issues and gain approvals of generic products.
2) Maximization of its generic and specialty pharmaceutical platforms through pipeline of potential launches representing billions in sales.
3) Optimization of its generic research and development pipeline including first-to-file opportunities representing $19 billion in potential sales.
4) Pursuit of business development to accelerate growth including advancement of its next-generation brand pipeline programs.
Driving Performance Excellence in the Regulatory Affairs Function at Medical ...Best Practices
This document summarizes research from a benchmarking study of regulatory affairs practices at 32 leading medical device companies. Key findings include:
- Regulatory affairs structures are most commonly centralized, though some utilize decentralized or hybrid models. Larger companies tend towards more decentralized structures.
- Portfolio complexity, defined as the ratio of class III products, influences but does not solely determine staffing needs.
- On average, companies file over a dozen submissions annually with European regulators and over 60 submissions with Japanese regulators.
- Regulatory staff spend significant time (over 20% for most companies) managing change notices and documentation.
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
This resume summarizes Jason Gillette's experience in regulatory compliance and quality systems for life science companies over 17+ years. He currently serves as Vice President of Regulatory Compliance at Westminster Pharmaceuticals, where he helped the startup secure contracts with major wholesalers and distributors. Prior to this role, Gillette held regulatory and quality roles at several pharmaceutical and medical device companies, helping to ensure compliance with FDA regulations. He has extensive experience implementing quality management systems, conducting audits, and managing regulatory projects.
Deutsche Bank Health Care Conference May 30 2013impax-labs
Impax Laboratories provided a "Safe Harbor" statement noting that statements in the presentation involving the future are forward-looking and actual results could differ. Impax is committed to improving operations by addressing FDA issues, implementing quality enhancements, and moving in the right direction. The company is positioned for future growth through two platforms - generics targeting $25B in U.S. sales and brands focused on central nervous system conditions. Impax has a diversified generic pipeline, established competencies, and financial flexibility to support growth strategies including organic growth, partnerships, and M&A.
UBS Global Healthcare Conference May 22 2013impax-labs
- The document contains forward-looking statements about the company's future performance that involve known and unknown risks and uncertainties.
- The company has submitted responses to recent FDA observations and requested a meeting to ensure regulatory alignment. Significant improvements have been made to quality systems over the past two years.
- The company is committed to improving operations and moving in the right direction.
Effective Complaint Management: The Key to a Competitive Edge for Medical Dev...Cognizant
By establishing strong complaint management processes, medical device firms can make continuous improvements in patient safety, regulatory compliance and customer satisfaction.
Waste in hospitals - everywhere - is massive. Up to 50% of consumables and devices purchased are never used on a patient. Support activities are highly manual, repetitive and done by professional clinical staff...
This presentation sets out the strategic environment and discusses the development and successful implementation of a leading-edge process and supply chain solution for hospitals.
Bank of America Merrill Lynch Healthcare ConferenceImpaxLaboratories
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly for alternative dosage forms, and mergers and acquisitions mainly for alternative dosage forms.
Bank of America Merrill Lynch Health Care Conferene May 16 2013impax-labs
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly in alternative dosage forms, and mergers and acquisitions mainly in alternative dosage forms.
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...Torben Haagh
Want to learn more about how to cover gaps for IDMP implementation until July 1st 2016? Then join experts at the International Conference IDMP Implementation - Impact on Data, Systems and Processes taking place in Berlin from 24 – 25 June 2015.
There are limited places available, so make sure you secure your conference ticket today! Learn more here.
Don't miss this unique opportunity to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from:
• Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more.
Want to know more regarding this topic area? Then join us at our
IDMP Implementation - Impact on Data, Systems and Processes
24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany
For more information take a look at our agenda here: http://bit.ly/IDMP_agenda
Or visit our website: http://bit.ly/IDMP_website
Mann India SAP Service Offerings- IS Life ScienceMann-India
Mann-India Technologies provides SAP solutions tailored for life science companies. Their solutions are based on templates and best practices that can reduce implementation time. They offer cloud hosting to reduce costs. Mann-India has experience implementing SAP solutions for pharmaceutical processes such as batch management and electronic signatures. Their reusable objects and test scripts can further reduce time spent on implementation and testing.
Jefferies Global Healthcare Conference June 5 2013impax-labs
This document contains a "Safe Harbor" statement regarding forward-looking statements in the presentation. It notes several risks and uncertainties that could cause the company's future results to differ from forward-looking statements, including economic conditions, issues raised by the FDA in warning letters and observations, developing and commercializing pharmaceutical products, reductions in business with significant customers, the impact of competition, and other regulatory, legal and operational risks. It also provides an overview of the company's generic and branded product pipelines and growth strategies focusing on organic growth, partnerships, and M&A.
Laboratory and Pharmaceutical Quality Assurance ExpertMathias Atelefack
- The document provides a summary of a laboratory scientist's qualifications and experience over 20 years working in FDA-regulated laboratories in the pharmaceutical and biotechnology industries.
- It outlines his extensive experience overseeing quality assurance/quality control of pharmaceutical manufacturing processes and products, including tablets, capsules, liquids and medical devices.
- Recent roles included providing quality oversight for analytical laboratory operations at a pharmaceutical company, conducting data integrity audits at another pharmaceutical company, and consulting for various pharmaceutical manufacturers on quality assurance issues.
To keep pace with Health Authority mandates and requirements, there is a dire need for Pharma/Biotech/Cosmetic/Medical Device manufacturers or organizations to automate their processes. There comes the requirement for Regulatory software which should be flexible, secured and cloud-hosted aligning with region specific submission formats and data requirements.
As a specialist, Regulatory software provider Freyr offers proven tools for Publishing and submission, labeling, IDMP, Identity, Intelligence, document management and trial master files.
Gain more knowledge on specialized Regulatory tools.
China association of payment and clearing review and its membersGlobeBill
The document discusses China Association of Payment and Clearing (CAPC), including what it is, how to become a member, and current members. CAPC was founded in 2011 to promote cooperation and development in China's payment and clearing industries. It has over 200 member institutions, mostly banks but also payment companies. Major third-party payment companies that are members include AliPay, TenPay, and GlobeBill.
El documento describe de forma muy breve cómo funciona Internet. La información pasa por el router y el switch para ser enviada a Internet, donde es revisada y recogida antes de ser reciclada.
1) IDMP and RIM aim to harmonize product and regulatory information management but face challenges due to conflicting data sources and definitions between organizations and regions.
2) Implementing IDMP requires mapping diverse internal data systems and formats to a common IDMP data model and identifiers, which is complicated by varying data quality, timeliness, and ownership.
3) A master data management approach is needed to define authoritative sources, ownership, validation requirements, and change control to accurately populate the IDMP data containers and address issues across multiple systems over time.
Is your company ready to meet today’s challenges?Lidia Gasparotto
Visit us online at:
www.ibm.com/electronics/medicaldevices
Is your company ready to meet today’s challenges?
Ask yourself the following questions:
Are your products linked to clinical information systems? •
Is your supply chain optimized to track inventory, handle complaints and •
recalls and manage assets?
Can you comply efficiently with divergent security and privacy regula- •
tions?
Does your company get new products to market as quickly as your •
competitors?
Are your operations efficient and profitable? •
Does your company’s IT environment facilitate the formation of strategic •
alliances with insurance companies, HMOs, hospital buying groups and
supply chain logistics companies?
Can you reduce your tax liabilities through the use of commissionaires?
IBM has developed and refined the tools you need.
The document discusses the challenges faced by contract formulation laboratories in meeting increasing demands from pharmaceutical companies to rapidly develop new drugs while maintaining high quality and regulatory compliance standards. It outlines some of the key pressures contract labs face, including tight timelines, changing regulations, and managing resources effectively. It then provides an example of a university-affiliated contract lab, CUPSI, that enforces strict GMP training and procedures for students. The document concludes that as demands increase, contract labs need integrated quality management systems to streamline documentation, improve compliance, and reduce costs and risks.
This document discusses five steps for ensuring regulatory compliance when outsourcing business functions in highly regulated industries. It begins by explaining how strict regulations in industries like pharmaceuticals and food production present challenges for outsourcing. It then provides five steps companies can take to help outsourcing providers maintain compliance: 1) establish regulatory frameworks, 2) develop well-trained teams, 3) deploy knowledge retention strategies, 4) create a compliant workplace culture, and 5) maintain accountable processes. The document concludes with a case study of how one company improved regulatory compliance and reduced staff turnover by outsourcing certain functions.
Batch Manufacturers Require More Robust, Dock-to-Dock Control SystemsARC Advisory Group
Aware of the many choices in products and services, the consumer is conscious
of product price to value and demanding increased product quality,
safety, variety, and convenience. Most industries with batch manufacturing
processes are consolidating, requiring fewer plants to produce an
increased variety of products.
To survive, businesses that employ batch control processes must maximize
return on their assets while satisfying constantly changing consumer demands.
New government regulations continue to increase business costs.
Business and manufacturing process automation and integration have become
critical to business success.
While the functionality and standardization of commercial
off-the-shelf batch control systems has
increased dramatically in the last few years, they still
lack functionality needed to meet current and future
business requirements in the fine chemical, pharmaceutical,
food, and beverage industries. Standards
have been rapidly evolving and suppliers continue to
increase functionality needed to meet user business
requirements. Manufacturers in these industries can now develop an
automation strategy to meet current and future business needs using standard
products based on standards and not limited by technology.
Impax provides concise summaries of forward-looking statements and highlights its focus on four key areas:
1) Continued focus on quality to resolve regulatory issues and gain approvals of generic products.
2) Maximization of its generic and specialty pharmaceutical platforms through pipeline of potential launches representing billions in sales.
3) Optimization of its generic research and development pipeline including first-to-file opportunities representing $19 billion in potential sales.
4) Pursuit of business development to accelerate growth including advancement of its next-generation brand pipeline programs.
Driving Performance Excellence in the Regulatory Affairs Function at Medical ...Best Practices
This document summarizes research from a benchmarking study of regulatory affairs practices at 32 leading medical device companies. Key findings include:
- Regulatory affairs structures are most commonly centralized, though some utilize decentralized or hybrid models. Larger companies tend towards more decentralized structures.
- Portfolio complexity, defined as the ratio of class III products, influences but does not solely determine staffing needs.
- On average, companies file over a dozen submissions annually with European regulators and over 60 submissions with Japanese regulators.
- Regulatory staff spend significant time (over 20% for most companies) managing change notices and documentation.
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
This resume summarizes Jason Gillette's experience in regulatory compliance and quality systems for life science companies over 17+ years. He currently serves as Vice President of Regulatory Compliance at Westminster Pharmaceuticals, where he helped the startup secure contracts with major wholesalers and distributors. Prior to this role, Gillette held regulatory and quality roles at several pharmaceutical and medical device companies, helping to ensure compliance with FDA regulations. He has extensive experience implementing quality management systems, conducting audits, and managing regulatory projects.
Deutsche Bank Health Care Conference May 30 2013impax-labs
Impax Laboratories provided a "Safe Harbor" statement noting that statements in the presentation involving the future are forward-looking and actual results could differ. Impax is committed to improving operations by addressing FDA issues, implementing quality enhancements, and moving in the right direction. The company is positioned for future growth through two platforms - generics targeting $25B in U.S. sales and brands focused on central nervous system conditions. Impax has a diversified generic pipeline, established competencies, and financial flexibility to support growth strategies including organic growth, partnerships, and M&A.
UBS Global Healthcare Conference May 22 2013impax-labs
- The document contains forward-looking statements about the company's future performance that involve known and unknown risks and uncertainties.
- The company has submitted responses to recent FDA observations and requested a meeting to ensure regulatory alignment. Significant improvements have been made to quality systems over the past two years.
- The company is committed to improving operations and moving in the right direction.
Effective Complaint Management: The Key to a Competitive Edge for Medical Dev...Cognizant
By establishing strong complaint management processes, medical device firms can make continuous improvements in patient safety, regulatory compliance and customer satisfaction.
Waste in hospitals - everywhere - is massive. Up to 50% of consumables and devices purchased are never used on a patient. Support activities are highly manual, repetitive and done by professional clinical staff...
This presentation sets out the strategic environment and discusses the development and successful implementation of a leading-edge process and supply chain solution for hospitals.
Bank of America Merrill Lynch Healthcare ConferenceImpaxLaboratories
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly for alternative dosage forms, and mergers and acquisitions mainly for alternative dosage forms.
Bank of America Merrill Lynch Health Care Conferene May 16 2013impax-labs
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly in alternative dosage forms, and mergers and acquisitions mainly in alternative dosage forms.
Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confir...Torben Haagh
Want to learn more about how to cover gaps for IDMP implementation until July 1st 2016? Then join experts at the International Conference IDMP Implementation - Impact on Data, Systems and Processes taking place in Berlin from 24 – 25 June 2015.
There are limited places available, so make sure you secure your conference ticket today! Learn more here.
Don't miss this unique opportunity to hear expert presentations, take part in interactive workshops and meet with IDMP experts from around the world including participation from:
• Pfizer Inc. • Boehringer-Ingelheim Pharma GmbH & Co. KG • F. Hoffmann-La Roche Ltd. • Marr Consultancy Ltd • GE Healthcare • A.E.Tiefenbacher GmbH & Co. KG • Bundesinstitut für Arzneimittel und Medizinprodukte • Bundesverband der Arzneimittel-Hersteller e.V. • MEDA Pharma GmbH & Co. KG • Mylan EPD, Inc. • Janssen Pharmaceuticals, Inc. • Novartis Pharma AG and many more.
Want to know more regarding this topic area? Then join us at our
IDMP Implementation - Impact on Data, Systems and Processes
24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany
For more information take a look at our agenda here: http://bit.ly/IDMP_agenda
Or visit our website: http://bit.ly/IDMP_website
Mann India SAP Service Offerings- IS Life ScienceMann-India
Mann-India Technologies provides SAP solutions tailored for life science companies. Their solutions are based on templates and best practices that can reduce implementation time. They offer cloud hosting to reduce costs. Mann-India has experience implementing SAP solutions for pharmaceutical processes such as batch management and electronic signatures. Their reusable objects and test scripts can further reduce time spent on implementation and testing.
Jefferies Global Healthcare Conference June 5 2013impax-labs
This document contains a "Safe Harbor" statement regarding forward-looking statements in the presentation. It notes several risks and uncertainties that could cause the company's future results to differ from forward-looking statements, including economic conditions, issues raised by the FDA in warning letters and observations, developing and commercializing pharmaceutical products, reductions in business with significant customers, the impact of competition, and other regulatory, legal and operational risks. It also provides an overview of the company's generic and branded product pipelines and growth strategies focusing on organic growth, partnerships, and M&A.
Laboratory and Pharmaceutical Quality Assurance ExpertMathias Atelefack
- The document provides a summary of a laboratory scientist's qualifications and experience over 20 years working in FDA-regulated laboratories in the pharmaceutical and biotechnology industries.
- It outlines his extensive experience overseeing quality assurance/quality control of pharmaceutical manufacturing processes and products, including tablets, capsules, liquids and medical devices.
- Recent roles included providing quality oversight for analytical laboratory operations at a pharmaceutical company, conducting data integrity audits at another pharmaceutical company, and consulting for various pharmaceutical manufacturers on quality assurance issues.
To keep pace with Health Authority mandates and requirements, there is a dire need for Pharma/Biotech/Cosmetic/Medical Device manufacturers or organizations to automate their processes. There comes the requirement for Regulatory software which should be flexible, secured and cloud-hosted aligning with region specific submission formats and data requirements.
As a specialist, Regulatory software provider Freyr offers proven tools for Publishing and submission, labeling, IDMP, Identity, Intelligence, document management and trial master files.
Gain more knowledge on specialized Regulatory tools.
China association of payment and clearing review and its membersGlobeBill
The document discusses China Association of Payment and Clearing (CAPC), including what it is, how to become a member, and current members. CAPC was founded in 2011 to promote cooperation and development in China's payment and clearing industries. It has over 200 member institutions, mostly banks but also payment companies. Major third-party payment companies that are members include AliPay, TenPay, and GlobeBill.
El documento describe de forma muy breve cómo funciona Internet. La información pasa por el router y el switch para ser enviada a Internet, donde es revisada y recogida antes de ser reciclada.
For thirteen years, Resource Interactive has studied retailers online during their high-stakes holiday season. Why the holiday focus? We’ve noticed that certain competitive advantages become highly conspicuous during these days of intense consumerism—the holiday season can either make or break the year for retailers. In other words, it offers us the opportunity to survey a retailer’s biggest moment and best effort.
Of the 40 online retailers we surveyed using our OPEN framework, we’ve chosen to feature fifteen in the final report. We focused on the social media, mobile and web site innovation, uncovering quite a few bright spots in a season of innovation and inventiveness. See how retailers fared—from Amazon to Zappos and everywhere in between—and take a look at the most novel marketing moves of the holiday season, which will surely become the everyday fare of 2010. Are you ready?
Seminar on quantum automata and Languagesranjanphu
This document provides an overview of a seminar presentation on quantum automata and languages. The presentation covers topics such as bits and qubits as computational units, classical automata models like finite state automata and pushdown automata, probabilistic automata and stochastic languages, and various models of quantum automata like quantum finite state automata and their properties. The document also includes an agenda that lists the different sections to be covered in the presentation.
In this experiment conducted by Dr. Emoto, he placed cooked rice in two containers labeled "thank you" and "you fool". He had school children say the labels out loud each day passing the containers. After one month, the rice labeled "thank you" was fresh while the rice labeled "you fool" was discolored and rotten, showing that positive and negative words can impact physical systems.
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This document discusses trends in enterprise labeling from a survey of 500 supply chain professionals. The top trends are: 1) Businesses are standardizing labeling for consistency and efficiency across global supply chains; 2) Labeling needs to be integrated with business systems and allow for dynamic, data-driven changes; 3) Labeling intersects the supply chain at all levels from production to distribution; 4) Technology advances like cloud computing are influencing how labeling solutions are deployed and accessed.
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The medical device industry is in the midst of fundamental change. IBM’s approach to servicing medical device companies is designed to meet real-world needs today and in the future.
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The future of medical device mfg executive briefPatti Stoll
The document discusses challenges facing the medical device manufacturing industry and how next-generation ERP systems can help address them. It notes that the aging Baby Boomer population will increase demand for medical devices but that cost containment measures pose challenges. It advocates that ERP systems can help manufacturers meet this rising demand while controlling costs through improved agility, collaboration, and ability to adapt to changing needs. Specifically, it recommends the Infor Industrial Manufacturing for Medical Devices solution to help streamline operations from production to service to compliance.
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This document discusses coding technologies used to combat counterfeit pharmaceuticals. It describes overt coding methods like size, shape, and logos but notes these can be copied. Covert coding uses chemical or physical markers added invisibly. Regulatory barriers have hindered adoption of coding technologies but guidelines from the FDA have helped. Cost is also an issue, especially for generic drug makers. Future solutions may use nanotechnology and mobile phone verification to authenticate drugs for patients and ensure the correct personalized formulation.
Denny Ross, a food and beverage industry specialist with Loftware, Inc., answers 6 questions about challenges with labeling and how enterprise labeling solutions can help address them. Standardizing labeling through a centralized solution can help companies comply with regulations like FSMA and EU1169, avoid risks from mislabeled products, and streamline product recalls. Tight integration with other systems ensures accurate, up-to-date labeling while collaboration with suppliers through shared label templates reduces costs from relabeling. Flexible, scalable solutions support business growth through expansion and acquisitions.
This document discusses the importance and management of mature pharmaceutical products. Some key points:
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The document discusses the key findings of a survey on enterprise labeling trends. It identifies 5 major trends: 1) Businesses are standardizing labeling for consistency and efficiency. 2) Integrated, dynamic labeling is essential. 3) Labeling intersects the supply chain at all levels. 4) Technology advances are influencing labeling. 5) Evolving global regulations continue to impact labeling. The trends are based on input from leading global companies and a survey of over 500 supply chain professionals that inquired about current and future labeling challenges.
Global product serialization is well underway and many companies are not adequately prepared for it. The significant capital costs and lack of knowledge in successful implementation are keeping them behind.
Traceability in the food and beverage industryKaizenlogcom
Three technological advancements are enabling full traceability across food and beverage supply chains: big data, the Internet of Things, and cloud solutions. These technologies allow automatic collection and analysis of data from IoT devices to track products throughout the supply chain. An agile ERP system is needed to incorporate these technologies and give manufacturers a 360-degree view of their supply chain.
Traceability in the food and beverage industryKaizenlogcom
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2) Cloud solutions provide storage for this large volume of data.
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Maetrics: The ROI of Good Quality & ComplianceGeneris
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The document discusses the scope and implementation of lean aspects in the pharmaceutical industry. It begins by noting that pharmaceutical companies face challenges like rising costs and need to deliver quality products quickly within a competitive environment. While other industries have benefited from approaches like Lean and Six Sigma, the pharmaceutical industry has been slow to adopt lean manufacturing.
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The document discusses how enterprise labeling can help automotive companies address the complex challenges of their global supply chains. It notes that the automotive supply chain is highly complex, with parts sourced globally and assembly occurring thousands of miles away. Enterprise labeling can improve operational efficiency, meet customer and regulatory requirements, and enhance traceability. The document presents examples of large automotive companies that have implemented enterprise labeling solutions to gain benefits such as reduced costs, improved quality and responsiveness to customers.
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Enterprise Labeling for the Medical Device Industry
1. 1
ENTERPRISE LABELING FOR THE MEDICAL DEVICE INDUSTRY
STAY COMPLIANT WHILE IMPROVING
SUPPLY CHAIN OPERATIONS
2. 2
IT’S TIME FOR POWERFUL NEW SOLUTIONS IN MEDICAL
DEVICE LABELING
For medical device manufacturers, labeling is growing in importance, and there are a number of
reasons why.
REGULATORY REQUIREMENTS
In a world of complexity and regulation, few industries are as complex and regulated as medical devices. Standards
for quality, safety, and procedural accuracy are exceedingly high—as are the stakes—and failure to meet these
standards can have profound consequences, including loss of life. Labeling is central to compliance with regulations.
Within its Quality Systems regulation, the US Food and Drug Administration (FDA) has Code of Federal Regulations
(CFR) labeling-related requirements that must be followed in order to meet Current Good Manufacturing Practice
(CGMP).
Some FDA labeling regulations are specific to medical devices, but there are also more general requirements such
as regulations governing electronic products, sterilization methods, and the labeling of products containing natural
rubber/latex.
With a goal of improving patient safety, the FDA is also phasing in a unique device identifier (UDI) system that will
enable medical devices to be identified throughout the entire distribution and use cycle. UDI requirements, which
address issues such as traceability, are impacting both US companies and multinationals that market in the US.
Another key regulation of the FDA that can help streamline workflow for medical device companies is the use of
electronic signatures in place of paper records and handwritten signatures. Compliance with 21 CFR Part 11 within
labeling operations can further reduce complexity, manage audit trails, and boost productivity.
When it comes to regulatory compliance, labeling matters.
A WIDELY DISPERSED SUPPLY CHAIN
Another challenge facing the medical device world–and one that can be solved through better labeling–is the fact
that today’s supply chains are widely dispersed. Labeling is essential to the smooth flow of the medical device supply
chain, where problems can arise at any juncture in the chain, or may “wait” to manifest in a finished product.
COMPETITIVE PRESSURES
For medical device makers, global competition is fierce, and competitive pressures—as well as pressures from health
care providers and insurers to keep costs from skyrocketing—result in an increasing focus on maintaining costs and
on operational efficiency. Here, the right labeling approach can yield big dividends.
3. 3
MARKET EXPANSION
Entering new markets is essential for success.They’re where many of the opportunities for growth reside. But each
new market presents unique challenges and unique labeling needs, as medical device companies must satisfy local
language, shipping, and regulatory demands.
TAKING A STRATEGIC PERSPECTIVE ON LABELING
In this world of complexity and regulation, labeling must be viewed from a strategic perspective. Yesterday’s approach
to labeling, often done on an operational and departmental level, with little attention paid to standards or policies,
has resulted in a disparate, piecemeal labeling “solution” that’s expensive, inefficient, and error-prone. Shipments
are rejected, or languish in customs. Lost or—worse—faulty product shipments can’t be tracked, putting device
manufacturers at risk. Opportunities to reinforce brand are missed.
Today, global medical device companies increasingly look at labeling from a strategic perspective. They
recognize that labeling is a critical mechanism for maintaining compliance, ensuring brand consistency,
improving operational efficiency, and supporting business growth.
WHAT HAPPENS IN THE ABSENCE OF A STRATEGIC
LABELING PROCESS
Failure to treat labeling as a strategic process can prove costly. Without a strategic approach to labeling, a medical
device company will experience:
EXCESSIVE REGULATORY COSTS
Medical device companies must comply with specific regulatory requirements in each market where their products
are sold.This may mean label changes multiple times each year with changes that must be understood, designed,
approved and implemented. Failure to rapidly respond to regulatory changes results in supply disruptions and lost
revenue.
CONFLICTING LABEL DATA
Medical device manufacturers have invested heavily in enterprise-wide business systems. Yet device and packaging
labels are often created using disparate processes and data that aren’t integrated with a company’s core system.
Thus, they aren’t drawing on data that is the single source of truth. (Nor are they able to tap the business rules laid out
in an enterprise system.) The resultant errors, inefficiencies and mislabeling can significantly impact the bottom line.
LOCAL LABELING INEFFICIENCIES
In today’s global supply chains, product design, manufacturing and packaging processes happen around the world.
In the past, label design, control, approval and printing were driven locally. While they adapted to regional restrictions,
4. 4
CASE IN POINT
ACHIEVING UDI COMPLIANCE ENABLES
A EUROPEAN MANUFACTURER TO
MARKET THEIR PRODUCTS IN THE US
When it comes to orthopedic, urological, and dental prophylaxis
devices, this European-based manufacturer is a market leader with a
global distribution network.The US is an important market for them, so
certification from the Food & Drug Administration is essential. As the date
for the first phase of the FDA’s Unique Device Identification system neared
(UDI), they recognized the need for a labeling process that would enable
them to meet the FDA mandate.Their existing labeling approach lacked
support for the symbologies required for UDI. Further, the existing solution
relied on error-prone manual data entry, resulting in costly mislabeling, and
print speed issues were impacting production.
Meeting UDI requirements, improving quality and speeding up
production with Loftware
This medical device manufacturer looked to Loftware to meet their labeling
needs. With Loftware, they have been able to:
• Use business logic as their platform for
handling UDI and other regulations
• Obtain FDA certification to continue selling in the US
• Provide traceability for all of their products
• Improve label quality by using data from the
company’s ERP system, a “single source of truth”
• Substantially decrease print time to less than one second.
5. 5
the variety of labeling solutions and systems that resulted often lacked accuracy and were operationally inefficient.
This hampered a manufacturer’s ability to meet market requirements in a timely manner, increasing the risk of supply
chain disruption due to regulatory action. It also meant that, when a local labeling system was down, production
would shut down as well.
INCONSISTENT BRANDING
Brands convey expertise, innovation, breadth of care, safety, and concern for the patient. Disjointed
labeling processes make it challenging to consistently apply branding guidelines and standards to globally
manufactured and distributed products. This can translate into lost sales, increased regulatory scrutiny,
delayed entry into new markets—and even place patient safety at risk. With the wrong approach to labeling,
for instance, it’s difficult, and perhaps even impossible, to track down recalled product batches.
INTEGRATED LABEL PROCESSES PROMOTE
QUALITY AND EFFICIENCY
When labeling is integrated into the enterprise business process, as well as with an existing authoring solution, rather
than existing in a stand-alone system, processes are simplified and non-value added activities are reduced. Loftware
enables operators to perform their value-added manufacturing, packaging, and distribution tasks without having to
access separate labeling systems or worry about keeping labeling synchronized with process or operational data.
Loftware applies business rules to operational data to automatically determine the right label format, content and
device based on the context of the business transaction.
DATA- AND RULES-DRIVEN LABELING ENABLES RAPID RESPONSE TO CHANGING REGULATIONS
Loftware enables medical device companies to rapidly respond to changing regional and international regulatory
requirements for labeling, including those mandated by the FDA’s Unique Device Identifier systems. By leveraging
a built-in business rules engine, companies can support labeling variations using configurable rules in a controlled
manner, removing the risk of manual errors and mislabeling. Using data-driven label content and configurable
business rules provides the flexibility to address requirements quickly while minimizing validation and approval
activities necessary to implement those label changes into production. For example, companies can now configure
more streamlined approval workflows and eSignatures within their Loftware labeling solution in a validated, 21 CFR
part 11–compliant environment.
FLEXIBLE APPROACH HELPS MEET CUSTOMER-SPECIFIC/PRIVATE LABEL REQUIREMENTS
Organizations within the medical device supply chain are increasingly required to respond to their customer and
partner labeling demands.These requirements are varied: logo placement or other branding demands, language
6. CASE IN POINT
ELIMINATING SITE-SPECIFIC LABELING BUILDS
OPERATIONAL EFFICIENCY
For nearly 50 years, this medical device maker has been dedicated to developing innovative products that
better patient outcomes, and to improving the operational processes that facilitate this. Several years ago,
they identified a significant operational problem: a site-specific labeling approach at facilities throughout the
United States, as well as in Central America and France.
In scrutinizing this approach, the company discovered that they had a number of redundant data repositories
outside of their Oracle ERP. Some sites used Access, others used Excel, and there were many discrepancies
between Oracle and these satellite databases. Sites also relied on manual data entry that was highly
susceptible to human error.The label printing process was manual as well, with labeling templates selected
manually during production, and data flows that were poorly documented. The resulting operational
inefficiencies were costly.
Eliminating data redundancy and improving operational efficiency with Loftware
When this device maker began working with Loftware, they were quickly able to replace their piece-parts
approach to labeling with a unified, enterprise-wide solution that tapped their Oracle ERP as the single source
of truth. Error-prone manual data entry and multiple sources of disparate data have been eliminated.To
help meet government regulations, and best practices, Loftware supports a number of industry standards,
including ISO, ANSI 3182, EDI, GS 1128 barcoding, static G10 barcoding – and is helping this company as
they adopt the Unique Device Identifier (UDI) standards now being phased in by the FDA.
With Loftware, this medical device maker is able to:
• Eliminate data redundancy
• Reduce downtime
• Speed up problem resolution, especially in the area of data reconciliation
• Minimize customer returns
• Decrease rework and relabeling
They’re also better able to support their business messaging and branding initiatives, and meet new
and evolving regulations in a growing market for them.
7. 7
variations, location-specific information, country-specific regulations, parts labeling that conforms to a customer’s
existing systems, labeling that enables health care providers to better monitor patient care and help them achieve
faster reimbursements. With Loftware, medical device manufacturers are able to quickly respond to customers’
requirements, reducing what was once a month-long process or longer to a matter of a few days.
ENTERPRISE LABEL PRINTING SUPPORTS THE GLOBAL ENTERPRISE
Loftware’s Enterprise Labeling Solutions enable medical device companies to produce labels anywhere in the global
landscape — labels based on approved templates and using common labeling infrastructure.
With an enterprise approach, medical device companies can ensure consistency by controlling label
content and format including layout, graphics, text and barcodes. In addition to labeling, corporate branding
guidelines can be deployed with minimal time and involvement. With Loftware, product labels will project a
global brand image regardless of where products are manufactured, packaged or sold.
A MISSION-CRITICAL PROCESS DEMANDS A MISSION-CRITICAL
SOLUTION
Across the medical device landscape, labeling is increasingly recognized as a mission-critical process that helps
further an organization’s strategic goals. First and foremost: meeting exacting regulatory compliance standards.
This means a labeling solution that supports CGMP-compliance, along with supporting other countries’ regulatory
demands, including those in newer export/import markets where standards are emerging and continually evolving. In
addition to offering labeling that helps ensure compliance, a labeling solution should be able to stand up to regulatory
audit demands.
Beyond regulation, medical device makers require a labeling solution that’s standardized and centralized when
necessary, and that taps into the data and business rules of existing enterprise systems. Such a solution enables
organizations to become more operationally efficient — saving on costs, avoiding expensive mistakes, and ensuring
that even the most remote facility is in compliance with governmental and industry regulations, while also meeting
overall internal branding standards.
That’s why some of the world’s foremost medical device manufacturers rely on Loftware to help them take a strategic
approach to labeling.
See how Loftware can provide you a competitive edge to stay compliant while improving the bottom line. Visit www.
loftware.com and keep up with the latest industry news by subscribing to our Blog.
8. PORTSMOUTH, NH, US • GERMANY • UK • SINGAPORE WWW.LOFTWARE.COM
Loftware, Inc. (www.loftware.com) is the global market leader in Enterprise Labeling
Solutions with more than 5,000 customers in over 100 countries. Offering the industry’s most
comprehensive labeling solution, Loftware’s enterprise software integrates SAP®, Oracle®
and other enterprise applications to produce mission-critical barcode labels, documents, and
RFID Smart tags across the supply chain. Loftware’s design, native print, and built-in business
rules functionality drives topline revenue, increases customer satisfaction, and maximizes
supply chain efficiency for customers. With over 25 years of industry leadership, Loftware’s
Enterprise Labeling Solutions and best practices enable leading companies to meet their
customer-specific and regulatory requirements with unprecedented speed and agility.