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Excel Spreadsheet Validation for FDA 21 CFR Part 11 This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. Live Tuesday, January 31, 2012 10:00 AM PST | 01:00 PM EST, Duration:90 Minutes $245.00
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Key Steps for Risk Assessment The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as those of the regulators and thereby significantly reduces your companies exposure to audit failures. Live Tuesday, January 31, 2012 10:00 AM PST | 01:00 PM EST , Duration:60 Minutes $245.00
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Efficient Computer System Validation - 10 Easy Steps This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Live Wednesday, February 1, 2012 10:00 AM PST | 01:00 PM EST, Duration:75 Minutes $245.00
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Residual Moisture Testing - Proven Techniques This webinar will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-died products in vials, to foods. Live Wednesday, February 1, 2012 10:00 AM PST | 01:00 PM EST, Duration:90 Minutes $245.00
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Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. Live Thursday, February 2, 2012 10:00 AM PST | 01:00 PM EST, Duration:90 Minutes $245.00
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| DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions | |
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This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. Recorded View Anytime Duration:90 Minutes $295.00
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| Excel Spreadsheet Validation to Eliminate 483s | |
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This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Recorded View Anytime Duration:75 Minutes $295.00
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| Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained | |
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The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Recorded View Anytime Duration:60 Minutes $295.00
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| Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained | |
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Duration:90 Minutes $50.00
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| Understanding the New USP Chapter 1224 for Transfer of Analytical Methods | |
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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 Duration:75 Minutes $295.00
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