Understanding the ERES 2016 - 21 CFR Part 11: Understanding the ERES Regulation for Compliance Success - By Compliance Global Inc

Overview:
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.
Why Should You Attend:
Software is rapidly becoming the preferred CGMP training tool for most regulated companies, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. The U.S. FDA continues to look more carefully into companies use of software applications for CGMP compliance and record keeping, in CAPA, calibration, SOPs, audits, submissions, adverse events reporting, ERP, and similar.
Pt 11 V&V is designed to prove that such software programs provide the same data integrity, security, retention / storage, retrievability accuracy as the previous “paper” systems provided. Regulatory auditors are more comfortable with delving into software issues.
Recent problems in unrelated industries show the dangers of neglecting thorough, and risk based, software verification and validation activities. Effective and real world software V&V is even more important in today’s resource-constrained industrial environment. This discussion will focus on a preferred U.S. FDA documentation "model" in CGMP applications requiring documented compliance to 21 CFR Part 11. Non-software driven means of compliance to some of Pt 11’s requirements will also be discussed.
Areas Covered in this Webinar:
This webinar will address software that is used to support / document the Quality System, 21 CFR Part 11. It will focus on a field-tested (FDA and EU) “model” having 11 elements of document modules that can be used for all software validation documentation. A manufacturer is responsible to identify these requirements as part of their Validation Master Plan and implement them as part of their company’s effective software V&V process.
Learning Objectives:
21 CFR 11 Verification or Validation -- FDA Expectations
The Project Validation Plan
The SRS and Part 11 subparts
An FDA-accepted Documentation "Model"
Software and Non-software V&V test cases
When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
The FDA’s 11 Key V&V Documentation Elements
“White Box” and “Black Box” Validations
GAMP / Other Considerations
Who Will Benefit
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA/RA Personnel
R&D Professionals
Engineering Professionals
Production Personnel
Operations Professionals
Consultants
Speaker Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 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 including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. 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.