Live Webinar : Software / Firmware Verification and Validation to Meet Regulatory Requirements

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries"

Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries.

Description

The 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".

This webinar will address software that is:

1) As-Product;

2) In-Product;

3) Process and/or In Production and Test Equipment; and

4) The Quality System / CGMPs.

A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process.

Why you should attend

Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries.  A quick review of Internet forums will show much confusion about the subject.  Software is being developed for medical imaging, and even thought control of computers.  It is increasingly being used for e-records and e-signatures. The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing and validation phases, since replication of software is relatively defect-free.  Regulatory auditors are more comfortable with delving into software isssues.     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 various applications, including ERP, in-device, as-device, process/equipment control, and cGMP data / 21 CFR Part 11 (and EU Annex 11) applications.

Areas Covered

  • Verification or Validation -- FDA Expectations
  • An FDA- [and ISO-] accepted Documentation "Model"
  • The FDA’s 11 Key V&V Documentation Elements
  • The Project V&V Plan
  • Product and Process / Test / Facilities / Equipment Software V&V
  • When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
  • “White Box” and “Black Box” Validations
  • IEC 62304, GAMP® / Other Considerations

Who will Benefit

• Corporate Management

• QA

• RA

• R&D

• Engineering

• Production

• Marketing

Personnel in FDA- and EU MDD / MDR-regulated industries, Devices, Combination Products 

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

John E Lincoln

Principal, J. E. Lincoln and Associates LLC

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and 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, he 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 is a graduate of UCLA.

Back to Top