John E.  Lincoln speaker of compliance global

11
Wednesday
May, 2016

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700348

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21 CFR Part 11: Understanding the ERES Regulation for Compliance Success

The verification and validation of medical industry software used in CGMP compliance records and defined under 21 CFR 11, “Electronic Records / Electronic Signatures” is coming under increased scrutiny by the U.S. FDA. 

This webinar will address the use of the U.S. FDA’s 21 CFR part 11 compliance, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. A field-tested Part 11 SW V&V documentation “model” will be featured.

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John E.  Lincoln speaker of compliance global

16
Wednesday
December, 2015

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700098

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The FDAs DHF, DMR and DHR Design Dossier for Documentation

The FDA's Design History Files, Device Master Records, Device History Record, and the EU's MDD TF/DD -- Documentation to meet their different purposes and device classifications.  This webinar will examine the existing and proposed requirements for the U.S. FDA's Design History File (DHF) per the CGMPs, 21 CFR 820.30 (j) -- including its derivitive documents, the DMR (Device Master Record) and DHR (Device History / Lot Record).  It will consider the European Union's MDD Technical File /Design Dossier requirements (similarities / differences), and evaluate the documents' differing purposes / goals, as well as the two  (FDA’s and EU’s) different device classification schemes.

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John E.  Lincoln speaker of compliance global

30
Tuesday
June, 2015

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700045

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Software Verification and Validation in Medical Industry

The verification and validation of medical industry software is coming under increased scrutiny by the U.S. FDA.  This webinar will address the use of the FDA, GAMP, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. A field-tested SW V&V documentation model will be featured.

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John E.  Lincoln speaker of compliance global

17
Tuesday
March, 2015

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700015

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The Best Way to Develop or Improve a Master Validation Plan

How to develop or improve upon a Master Validation Plan / Validation Master Plan or System that meets U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements.

FDA Warning Letters and recent high-profile recalls indicate major cGMP regulations deficiencies in many companies.

One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.  Starting with a Validation Master Plan, evaluating its elements against ISO 14971 process hazard analysis / risk management plan, allows development of meaningful product validations.  The roles of different V&V protocols.  How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, time).

A matrix simplifies “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked.  The QMS and 21 CFR Part 11 must also be considered.

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John E.  Lincoln speaker of compliance global

10
Tuesday
March, 2015

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700009

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U.S. FDA's Latest "Strategic Priorities" Initiative - 2014 - 2018

The FDA has added a "Strategic Priorities" initiative that can assist companies to proactively address areas of GMP concern. This webinar discusses their latest / second “Priorities”, for the period of 2014 through 2018.  It will address the major shift in the emphasis of the U.S. FDA cGMP compliance audits, clinical trial phases, product submissions and company response requirements.

All regulatory areas are under evaluation by the FDA, and need to be revisited by a company's QA/RA and its senior management.  These “Priorities” signal continued changes in FDA focus that have a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success.

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