The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
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 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsFDA 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 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsThis webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsOne of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsThis course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThe Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThis webinar will discuss what the new QMSR will require. A key element is the incorporation of ISO 13485 into the new 820 by reference. Major emphasis will be upon risk management in accordance with ISO 14971 (-:2019), which currently has only casual reference in 820.30. The FDA views risk management as an “essential systematic practice” to ensure that devices are safe and effective. If the proposed rule is finalized, it will enhance some parts of ISO 13485. Device manufacturers will need to enhance risk management procedures for specific devices and in all other areas of their businesses to align with the QMSR. Design Control (ISO 13485 7.3 Design and Development) will have limited application to Class I devices, but fully involve Class II and III (US classifications) as is currently done in the US but not the EU.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsVerification and validation requirements have always been part of the US FDA's GMPs. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system validations.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsThe 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 a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe 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 a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThere has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsThere has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsDue to the growth of the cybersecurity threat to electronic records, computer-controlled manufacturing, and medical devices, the US FDA has issued Guidances for Industry, e.g.: 1) "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Document", and 2) "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and 3) "Postmarket Management of Cybersecurity in Medical Devices" Draft.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsOne of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsClosed-loop CAPA mandates a repeatable, systematic Failure Investigation and Root Cause Analysis.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsOne of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsThis course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsOne of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsSoftware and related hardware design, development, verification, and validation are difficult to manage, document and control. This presentation focuses on the verification and validation planning and execution of software, after basic developmental testing and debugging. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsOne of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsVerification and validation requirements have always been part of the US FDA’s GMPs. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system validations.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsCAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsOne of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsOne of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsCAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsCAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsFDA 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 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsOne of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThis webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA 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 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsThis webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsOne of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsCAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsFDA 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 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsCAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsOne of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsDue to the growth of electronic records and electeronic signatures in CGMP documentation, as well as computer-controlled manufacturing, and medical devices, the US FDA has issued a draft Guidance for Industry, outlining its expectations for increased data integrity in this changing environment.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsDue to the growth of the cybersecurity threat to electronic records, computer-controlled manufacturing, and medical devices, the US FDA has issued Guidances for Industry, e.g.: 1) "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Document”, and 2) "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and 3) "Postmarket Management of Cybersecurity in Medical Devices" - Draft.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsSome of these new mobile apps / software functions are specifically targeted to assisting individuals in their own health and wellness management.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details21 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.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsCAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThe verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details21 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.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThis webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThe verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsCAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis 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 device industry QMS failings, as well as how ISO 13485 interfaces with the EU MDR (Medical Device Regulation).
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThis webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThe verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details21 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 to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThis webinar will examine the existing and proposed requirements for the U.S. FDA's DHF including its derivative documents, the DMR and DHR.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsThe verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe 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 a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsThe verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details21 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 to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsFDA 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 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsThis 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 its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsThis webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsFDA 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 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsIt will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details21 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 to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsDefined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe 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 a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world".
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsIt will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe 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 a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsThis webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world"
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsFDA 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.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsThe 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 a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsDefined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsThe last few years have seen an increase in product recalls. For this and other reasons, the U.S. FDA come under increasing negative public scrutiny.
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsThis webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsThe verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsThe 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 a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsThis webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsFDA 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.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsDefined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsThe last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based.
Speaker: John E Lincoln | View Anytime | Price: ¤190.00 | View DetailsThis webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.
Speaker: John E Lincoln | View Anytime | Price: ¤137.00 | View DetailsThe 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 a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤141.00 | View DetailsThere is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤162.00 | View DetailsThe 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 a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: ¤189.00 | View DetailsFDA 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.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤147.00 | View DetailsIt will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View DetailsThis webinar will discuss the 9 required elements of a Design Control System. It will consider different methods of implementation, and expectations of the U.S. FDA, proven by documentation.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View DetailsDefined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤189.00 | View DetailsFDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
Speaker: John E Lincoln | View Anytime | Price: ¤189.00 | View DetailsU. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820).
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View DetailsThe 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 a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Price: ¤189.00 | View DetailsThere is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems.
Speaker: John E Lincoln | View Anytime | Price: ¤189.00 | View DetailsThis webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.
Speaker: John E Lincoln | View Anytime | Price: ¤189.00 | View DetailsFDA 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.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View Details