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:
Process and/or In Production and Test Equipment and
The Quality System/CGMPs
A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process.
Why should you 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 in the Session:
Verification or Validation-FDA Expectations
The Project V&V Plan
An FDA-accepted Documentation "Model"
Product and Process/Test Facilities/Equipment Software V&V
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
IEC 62304,GAMP/Other Considerations
Who Will Benefit:
Senior management in Drugs,Devices,Combination Products,Biologics,Dietary Supplements
QA / RA
Software development,Programming,Documentation,Testing teams
Consultants,Others tasked with product,Process,Electronic records software V&V responsibilities
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.