John E. Lincoln
John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.
He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.
-
3-Hour Virtual Seminar on Part 11 Data Integrity and Cybersecurity – The Latest Developments
Data integrity has always been a key component of all the cGMP’s, only now taking on greater emphasis due to the use of electronic records / signatures. Cybersecurity is the preventing the theft / modification of e-records by unauthorized... -
Statistical Process Control (SPC) and Control Charts – In Accordance with Latest FDA Expectations
Statistical process control (SPC) is a method of quality control which employs statistical methods to monitor and control a process. It is one of the fifteen subpart requirements of the US FDA’s QS Regulation, 21 CFR 82, the Medical... -
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
Various firms are subject to various relevant and applicable federal regulations including, but not limited to, Good Laboratory Practice (GLP), Current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP). It is important for the industry to accurately understand... -
FDA Medical Device Changes and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety/effectiveness, or when... -
Mobile Device Apps and the FDA – Classification, Regulatory Requirements and Cybersecurity
The rapid expansion and broad applicability of software functions / applications deployed on mobile or other general-purpose computing platforms has created concerns with industry and the US FDA. This has resulted in the FDA focusing on the subset of... -
FDA Good Laboratory Practices (GLP’s)
This webinar is intended to provide guidance regarding Good Laboratory Practices (GLP) for use in pharmaceutical manufacturing and clinical trials, and for use by contract laboratories that support the regulated medical products industries. The Good Laboratory Practice regulations describe... -
New Drug Applications (NDA’s), Investigational New Drugs (IND’s) and the Drug cGMP’s
The regulation and control of new drugs for sale in the US is based on the NDA and the IND development and clinical process. Manufacturing of drugs must be under the Drug cGMPs, 21 CFR 210/211. For decades, the... -
ICH Q7 – GMPs for Active Pharmaceutical Ingredients
ICH Q7 is an internatioinal guidance document for recommended Good Manufacturing Practices for APIs. Within the world community, materials may vary as to their legal classification as an API. When a material is classified as an API in the... -
Cybersecurity – FDA Requirements Masterclass
Cybersecurity is the art of protecting networks, devices, and data from unauthorised access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information. Cybersecurity is the preventing the theft / modification of e-records by... -
FDA’s Plan for Modernizing the 510(k) Pathway – Meet the New Expectations
Almost two years ago the US FDA announced new steps necessary to modernize FDA’s 510(k) clearance pathway, but companies have been slow to respond, leading to unnecessary delay in achieving marketing clearance. This was reiterated one year ago in... -
3-Hour Virtual Seminar on Medical Device Risk Management – Implementing ISO 14971:2019
Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while... -
Examining and Implementation of ISO 13485:2016 Medical Device Quality Management System
This webinar will examine the basic elements of the EU’s QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical... -
Virtual Site Audits for FDA Regulated Industries
How can this little used internal inspection tool — “virtual” site cGMP-compliance audits — be used to assist in FDA regulatory compliance, and in meeting requirements for cGMP system audits / inspections of vendors, other remote located sites. Each... -
ISO 14971:2019 Medical Device Hazards and Risk Management – All you need to know
Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while... -
Blockchain Innovations that Connect and Protect the Supply Chain
This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain. The focus will be on how this can enhance cMGP compliance while it strengthens a company’s... -
Layered Process Audits for USFDA Regulated Industries
How can this new internal inspection tool – the Layered Process Audit (LPA) – be used to assist in FDA regulatory compliance, and in meeting requirements for an annual internal cGMP system audit / inspection. Each year companies are... -
Dietary Supplements cGMP – 21 CFR 111 Compliance
21 CFR part 111 (“the DS cGMP rule”) requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the cGMPs. This is to ensure the quality of the dietary supplement and... -
EO Sterilization Validation / Revalidation per ISO 11135
This webinar will outline the required elements of a successful ethylene oxide (EO) sterilization validation process for medical devices as required by ISO 11135:2014. Hardware / chamber and software considerations and required documentation. Temperature and humidity mapping, BIs /... -
FDA’s Latest UDI Labeling Requirements
The U.S. FDA is well into their long-anticipated Unique Device Identification System. Its purpose is to “establish a system to adequately identify devices through distribution and use”. It requires the development of a unique device identifier (UDI) in plain... -
3-Hour Virtual Seminar on U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative documents, the DMR and DHR. It will consider the European Union’s MDD TF/DD and... -
Human Factors Engineering to Satisfy the New IEC 62366-1, -2
IEC has released a new medical device usability standard, IEC 62366-1:2015, “Usability Engineering in IEC 62366-1:2015 — Part 1: Application of the new Usability Engineering Standard to Medical Devices” and “IEC/TR 62366-2:2 Part 2: Guidance on the application of... -
IQ, OQ, PQ in the Verification and Validation Process
This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big... -
FDA’s 21 CFR Part 11 Add-on Inspections
Medical devices software have become integral and indispensable in the controlling, running and monitoring of medical product processes, whether in the pharmaceuticals, medical device, biologics or dietary supplements industries. 21 CFR Part 11 addresses all electronic records; hence many... -
Verification vs Validation – Product, Process or Equipment and QMS Software
Verification and validation requirements for production and test equipment hardware and software / firmware have always been part of the US FDA’s GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems... -
3-Hour Virtual Seminar on Master Validation Plan – The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971... -
Additive / 3D Printing Manufacturing and Its Regulatory Issues
Additive Manufacturing (AM) or 3D Printing for manufacturing of medical devices is a new and rapidly expanding field, with rapidly expanding regulatory concerns. What is it? What are US FDA stated concerns? This webinar will focus on the key... -
510(k) Third Party Review Program – Latest Guidance, Changes, Challenges, and Opportunities
This webinar will examine the FDA’s latest draft guidance, “510(k) Third Party Review Program, Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” and the important areas for regulated companies to focus in the... -
USFDA’s 2019 – 2020 Strategic Priorities
This webinar will examine the FDA’s “Strategic Priorities” and related initiatives, with emphasis on 2019-2020. Such a review will focus on the broad range of issues a company’s senior management and QA/RA need to consider in their annual Management... -
Implementing a Risk-Based Internal cGMP Annual Audit Program
There is an on-going major shift in the emphasis of U.S. FDA cGMP compliance audits. These changes have a major impact on individual compliance objectives, efforts and measurements of success. The Agency is concerned with the major, high profile... -
U.S. FDA’s 510(k), IDE, and PMA Documentation, Submission and Approval Process
What are the various routes to US FDA device clearance / approval? The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through... -
The Master Validation Plan – The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971... -
510(k) Update and Medical Device Changes
This webinar will provide valuable guidance to regulated companies on latest 510(k) updates and in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S.... -
Key Regulatory Documents – Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier
There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market. And there are important differences. The cGMPs mandate Design Control and proof of compliance in the Design History... -
Failure Investigation, Root Cause Analysis – Tools and Techniques
Failure Investigations (FI) and Root Cause Analysis (RCA) are vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program, often required in product or equipment validations. Rigorous FI and RCA show a company’s Quality Management System... -
Reducing Human Error in Device Manufacturing
The International Electrotechnical Commission has recently published this updated standard, in two parts. It addresses an on-going concern by regulatory agencies in both the US and EU — human factors engineering / usability engineering. Usability can be defined as... -
Effective Design Control (21 CFR Part 820.30)
The FDA expects companies to perform meaningful, results driven Design Control activities as defined in in 21 CR 820.30, for both new and changed devices. ISO 13485:2016 now requires the same 10 elements under 7.3 Design and Development Planning.... -
Drafting a Software V&V Documentation Package and Protocol
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA. This webinar will address the use of the FDA, DAMP, and other applicable industry software validation models, coupled with the ISO 14971 /... -
Implementing a Risk-Based Internal cGMP Annual Audit Program
There is an on-going major shift in the emphasis of U.S. FDA cGMP compliance audits. These changes have a major impact on individual compliance objectives, efforts and measurements of success. The Agency is concerned with the major, high profile... -
IQ, OQ, PQ in the Verification and Validation Process
This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big... -
The New Usability Engineering Standard in IEC 62366-1:2015- Application and IEC/TR 62366-2:2016
IEC has released a new medical device usability standard, IEC 62366-1:2015, “Usability Engineering in IEC 62366-1:2015 — Part 1: Application of the new Usability Engineering Standard to Medical Devices” and “IEC/TR 62366-2:2 Part 2: Guidance on the application of... -
Process Verification and Validation
This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs. It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously... -
Sale!
U.S. FDA New Draft Guidance on UDI Label Form and Requirement
The U.S. FDA is well into their long-anticipated Unique Device Identification System. Its purpose is to “establish a system to adequately identify devices through distribution and use”. It requires the development of a unique device identifier (UDI) in plain... -
Sale!
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier
There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market. And there are important differences. The cGMPs mandate Design Control and proof of compliance in the Design History... -
Sale!
FDA’s New Draft Guidance on Data Integrity for cGMP Compliance
The U.S. FDA released the new Draft Guidance on “Data Integrity and Compliance with cGMP”. There remains some confusion as to the FDA’s current thinking with respect to electronic records and/or electronic signatures and their interpretation of 21 CFR... -
IQ, OQ, PQ in the Verification and Validation Process
This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big... -
Hazard Analysis and Product Risk Management under ISO 14971 and ICH Q9
The U.S. FDA has stated that the use of a medical device or pharmaceutical entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps... -
U.S. FDA’s Strategic Priorities – 2016 and Beyond
This webinar will discuss about the “Strategic Priorities” that the FDA has published to emphasize their future directions vis-a-vis regulated industry and public safety. Each year companies are to perform a complete review of their quality management system and... -
Current Regulations under FDA and HIPAA
There are potential pitfalls to the flow of medical information and a patient’s privacy rights under HIPAA. What was done years ago is no longer acceptable. This session will help you understand the basic requirements of HIPAA and FDA.... -
The FDA’s Guidance on Wireless Devices
The U.S. FDA released a guidance document on wireless medical devices, “Radio Frequency Wireless Tehnology in Medical Devices”. Its purpose is to address the growing use of wireless technology in medical devices in support of health care and new... -
Combination Drug/Device Products cGMPs – Final Rule
This training on combination product regulations will evaluate the chief areas of concern or change in the new cGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination... -
Robust Verification and Validation
This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now the FDA... -
Robust Corrective And Preventive Action (CAPA)
Vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program include: “Gatekeeper” capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis. Such a “closed-loop” CAPA system will meet / exceed CGMP requirements... -
Robust Verification and Validation
Description: This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now the... -
Robust Corrective And Preventive Action (CAPA)
Description: Vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program include: “Gatekeeper” capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis. Such a “closed-loop” CAPA system will meet / exceed CGMP... -
Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements
Description: This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now, the... -
IQ, OQ, PQ in the Verification and Validation Process
Description: This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and CGMP e-records / e-signatures. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in... -
Medical Device Changes and the 510(k)
Description: This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S. FDA’s current K-97-1 Memo... -
Failure Investigation, Root Cause Analysis – Tools and Techniques
Description: Failure Investigations (FI) and Root Cause Analysis (RCA) are vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program, often required in product or equipment validations. Rigorous FI and RCA show a company’s Quality Management... -
Prepare for Your cGMP Inspection
Description: This webinar will focus on the U.S. FDA’s FY 2013 cGMP audit issues, recent guidance documents and stated 2014 initiatives. Issues discussed should be a key consideration of a company’s Internal Audit Program, and annual Quality Management Review.... -
FDA’s New UDI Labeling Requirements
Description: All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21... -
The FDA’s New Guidance on Wireless Devices
Description: The U.S. FDA has just published their long-anticipated Unique Device Identification System Final Rule, on September 23, 2013. It’s purpose is to “establish a system to adequately identify devices through distribution and use.” It requires the development of... -
Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements
Description: The U.S. FDA released a new guidance document on wireless medical devices, “Radio Frequency Wireless Tehnology in Medical Devices”, on August 13, 2012. Its purpose is to address the growing use of wireless technology in medical devices in... -
Medical Device Changes and the 510(k)
Description: There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market. And there are important differences. The cGMPs mandate Design Control and proof of compliance in the Design... -
Robust Corrective And Preventive Action (CAPA)
Description: This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA’s current K-97-1... -
Robust Verification and Validation
Description: Vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program include: “Gatekeeper” capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis. Such a “closed-loop” CAPA system will meet / exceed CGMP... -
Clinical IT Inspection Readiness
Description: All Regulatory Agencies are entitled to come in to any company involved in clinical trials and review documentation supporting procedures and computerized systems, in as part of an Inspection. The most common regulations that will form the back-ground... -
U.S. FDA’s Strategic Priorities – 2016 and Beyond
Description: This webinar will discuss about the “Strategic Priorities” that the FDA has published to emphasize their future directions vis-a-vis regulated industry and public safety. Each year companies are to perform a complete review of their quality management system... -
Hazard Analysis and Product Risk Management under ISO 14971 and ICH Q9
Description: The U.S. FDA has stated that the use of a medical device or pharmaceutical entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable... -
U.S. FDA’s Strategic Priorities – 2015 and Beyond
Description: This webinar will discuss about two “Strategic Priorities” that the FDA has published to emphasize their future directions vis a vis regulated industry and public safety. Each year companies are to perform a complete review of their quality... -
U.S. FDA’s Strategic Priorities – 2014 and Beyond
Description: This webinar will examine the FDA’s recently instituted annual “Strategic Priorities” initiative, with emphasis on 2014, and future issues. Such a review will focus on the broad range of issues a company’s senior management and QA/RA need to... -
Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements
Description: This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now, the... -
Robust Corrective And Preventive Action (CAPA)
Description: This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA’s current K-97-1... -
Medical Device Changes and the 510(k)
Description: There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market. And there are important differences. The cGMPs mandate Design Control and proof of compliance in the Design... -
Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier
Description: This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now, the... -
Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements
Description: The U.S. FDA released a new guidance document on wireless medical devices, “Radio Frequency Wireless Tehnology in Medical Devices”, on August 13, 2012. Its purpose is to address the growing use of wireless technology in medical devices in... -
The FDA’s New Guidance on Wireless Devices
Description: The U.S. FDA has just published their long-anticipated Unique Device Identification System Final Rule, on September 23, 2013. It’s purpose is to “establish a system to adequately identify devices through distribution and use.” It requires the development of... -
FDA’s New UDI Labeling Requirements
Description: All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21... -
Prepare for Your cGMP Inspection
Description: This webinar will focus on the U.S. FDA’s FY 2013 cGMP audit issues, recent guidance documents and stated 2014 initiatives. Issues discussed should be a key consideration of a company’s Internal Audit Program, and annual Quality Management Review.... -
Failure Investigation, Root Cause Analysis – Tools and Techniques
Description: Failure Investigations (FI) and Root Cause Analysis (RCA) are vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program, often required in product or equipment validations. Rigorous FI and RCA show a company’s Quality Management... -
Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements
Description: This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now, the... -
Medical Device Changes and the 510(k)
Description: This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S. FDA’s current K-97-1 Memo... -
IQ, OQ, PQ in the Verification and Validation Process
Description: This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and CGMP e-records / e-signatures. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in... -
Robust Corrective And Preventive Action (CAPA)
Description: Vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program include: “Gatekeeper” capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis. Such a “closed-loop” CAPA system will meet / exceed CGMP... -
Robust Verification and Validation
Description: This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now the... -
Robust Verification and Validation
Description: Vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program include: “Gatekeeper” capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis. Such a “closed-loop” CAPA system will meet / exceed CGMP... -
Clinical IT Inspection Readiness
Description: All Regulatory Agencies are entitled to come in to any company involved in clinical trials and review documentation supporting procedures and computerized systems, in as part of an Inspection. The most common regulations that will form the back-ground... -
U.S. FDA’s Strategic Priorities – 2016 and Beyond
Description: This webinar will discuss about the “Strategic Priorities” that the FDA has published to emphasize their future directions vis-a-vis regulated industry and public safety. Each year companies are to perform a complete review of their quality management system... -
Hazard Analysis and Product Risk Management under ISO 14971 and ICH Q9
Description: The U.S. FDA has stated that the use of a medical device or pharmaceutical entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable... -
U.S. FDA’s Strategic Priorities – 2015 and Beyond
Description: This webinar will discuss about two “Strategic Priorities” that the FDA has published to emphasize their future directions vis a vis regulated industry and public safety. Each year companies are to perform a complete review of their quality... -
U.S. FDA’s Strategic Priorities – 2014 and Beyond
Description: This webinar will examine the FDA’s recently instituted annual “Strategic Priorities” initiative, with emphasis on 2014, and future issues. Such a review will focus on the broad range of issues a company’s senior management and QA/RA need to... -
Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements
Description : This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now,... -
Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements
Description : This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now,... -
Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier
Description : There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market. And there are important differences. The cGMPs mandate Design Control and proof of compliance in the... -
Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier
Description : There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market. And there are important differences. The cGMPs mandate Design Control and proof of compliance in the...
