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David Nettleton	21 CFR Part 11 - Compliance for Electronic Records and Signatures This webinar details the regulation and how it applies to computerized systems. Recorded View Anytime  Duration:75 Minutes $295.00
David R. Dills	Conducting Successful Product Complaint Investigations This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. Recorded View Anytime $295.00
Jeff Kasoff	The 510(k) Submission: Requirements, Contents, and Options This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Recorded View Anytime  Duration:60 Minutes $295.00
Jeff Kasoff	Equipment Validation, Tracking, Calibration, and Preventive Maintenance FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Recorded View Anytime  Duration:60 Minutes $295.00
Teri C. Soli	Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive. Recorded View Anytime  Duration:90 Minutes $295.00
Dr. Ludwig Huber	FDA's New Enforcement of 21 CFR Part 11 FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Recorded View Anytime  Duration:75 Minutes $295.00
Richard Poser	Risk-Based Validation of cGMP Systems This presentation will review a methodology for implementing Risk-Based Validation of test equipment, facilities and analytical instruments used in GLP, cGMP and GCP facilities. Recorded View Anytime $295.00
Edwin L Bills	Process Validation for Medical Device Manufacturers All medical device companies are required to review its manufacturing processes to determine which processes require process validation, and which processes may be qualified by other methods. Recorded View Anytime $295.00
Dr. Ludwig Huber	Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. Recorded View Anytime $295.00
John Chapman	Recalls & Vigilance-When to Report Complaints This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints. Recorded View Anytime $295.00