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Recorded Richard Poser Analytical Test Method Qualification and Validation The scientific and regulatory requirements for analytical test method validation change as drug products and medical devices are developed from R&D through pre-clinical, clinical and commercial phases It is important to know when to do what - unnecessary validation is costly and can delay development programs, while insufficient validation can mean rejection of an application. Recorded View Anytime $295.00 Richard Poser Software Vendor Qualification and Auditing Inspection and auditing of vendors which provide software used to support GXP manufacturing and testing will be explained and illustrated through audit forms, processes and checklists. Recorded View Anytime $295.00 Richard Poser Analytical Instrument and Equipment Qualification in Quality Laboratories The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. Recorded View Anytime $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 Richard Poser Internal 21CFR Part 11 Compliance Auditing of Computer Systems This presentation will describe a proven process for preparing a site for inspection of systems. Recorded View Anytime $295.00 << >>