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. If will focus on the 11 key software documents from an FDA Guidance Document.
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:
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.
NOTE: GAMP® is a registered trademark of ISPE. To learn more about GAMP®, visit www.ispe.org
Duration: 90 Minutes
Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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. John is a graduate of UCLA