Pack of SEVEN: Best Selling Medical Devices Webinars by GlobalCompliancePanel Actual Price:
Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly.
There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.
Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc
Risk-based Software Verification and Validation
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management. ..more
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
The Design History File and the Technical File / Design Dossier
John E Lincoln Consultant, Medical device and Regulatory affairs,
The DHF is a key element of Design Control under the GMPs, and is a major subject for review during a U.S FDA compliance audit.
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and working with clinical investigators.
Regulatory Complaint Handling, MDR's & Recalls Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms. Many medical device firms face regulatory issues as a result of inadequate complaint handling.
Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
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. ..more David R. Dills Industry Regulatory & Compliance Consultant, David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry. ..more John Chapman Regulatory Affairs Professional, John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. ..more
One major failing is lack of sufficient or targeted risk-based 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.
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