The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", 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:
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 issues. 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 / Part 11 applications.
Areas Covered in the Session:
Who Will Benefit:
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.
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Event Link : http://bit.ly/1KNlp7R