Webinar Search Results : 4 Upcoming webinars found.
John E Lincoln Wednesday, June 20, 2018
08:00 AM PDT | 11:00 AM EDT
Duration:3 Hours
Price: ¤290.00
by: John E Lincoln
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

John E Lincoln Wednesday, June 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John E Lincoln
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

John E Lincoln Wednesday, July 25, 2018
08:00 AM PDT | 11:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: John E Lincoln
3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements
This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

John E Lincoln Wednesday, August 15, 2018
08:00 AM PDT | 11:00 AM EDT
Duration:3 Hours
Price: ¤290.00
by: John E Lincoln
3-Hour Virtual Seminar on Verification vs Validation-Product, Process or Equipment and QMS Software
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 or ICH Q9, hazard analysis / risk management, allows development of meaningful product validations. Clear up definition confusion with suggested "working definitions".

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