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Recommendations for Cell Banks used in GXP testing
Ana Menendez
60 Min
Product Id: 702327
This webinar presents a best practices approach for preparing, characterizing and storing cell banks used for GXP analytical and bioanalytical test methods. It covers critical topics such as timelines for generation of cell banks, equipment, growth conditions, purity, consistency, and stability.
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Life Cycle Validation of GMP Potency Bioassays
Ana Menendez
90 Min
Product Id: 702195
This 90-minute webinar will provide guidelines for bioassay validation and regulatory documentation, the steps for technology transfer and commercial validation show how to implement the new USP chapters 1032, 1033 and 1034.
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Managing Immunogenicity Risk in Biopharmaceuticals
Ana Menendez
60 Min
Product Id: 701493
This Immunogenicity risk training Webinar will help you understand immunogenicity and analyzing risk factors to strategically develop biopharmaceuticals.
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Accelerating Bioassay Transfer in a GMP Environment
Ana Menendez
60 Min
Product Id: 700374
This Bioassays webinar will systematically outline the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.
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Implementation of the USP GMP Potency Bioassay Suite
Ana Menendez
60 Min
Product Id: 701275
This webinar on Potency Bioassays will show how to implement the parameters described in the new USP Bioassay suite to deliver compliant assays for Phase I/II, Phase III and commercial products.
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Validation of Bioanalytical Assays for Biologicals
Ana Menendez
75 Min
Product Id: 700214
This Validation of Bioanalytical Assays webinar describes logical approaches to efficiently develop assays that will deliver quality data.
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3-hr Virtual Seminar - Regenerative Medicine: An Introduction to FDA's Regulation of Cell Therapies and HCT/Ps Generally
Karl M. Nobert
3 hrs
Product Id: 702155
This 3-hr virtual seminar will cover the USFDA's regulation of cell therapies and HCT/Ps, FDA's labeling and promotional rules and the agency's current enforcement activities in the areas of cell and gene therapies, and HCT/Ps generally.
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Residual Moisture Testing - Proven Techniques
J. Jeff Schwegman
60 Min
Product Id: 701952
This training will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-dried products in vials, to foods.
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Environmental Monitoring and the Contamination Control Plan
Scott Sutton
95 Min
Product Id: 701241
This contamination control training will focus on how to use the EM data appropriately as part of a contamination control plan and also discuss about Designing and Managing a Microbiological Monitoring Program.
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Understanding the Harmonized Microbial Limits Tests - stressing the new compendial chapters, validation, verification and new expectations in USP <1111>
Scott Sutton
85 Min
Product Id: 701238
This biotech training will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products.
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Water System Compliance - Successful Sanitization Approaches for Trouble-Free Water Quality
T.C Soli
90 Min
Product Id: 701302
This Water system compliance training/webinar focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches.
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Water System Compliance - Implementing Changes to a Validated System
T.C Soli
90 Min
Product Id: 701303
This Water system compliance training will guide you through the changes to implement to Validate Water system and better understanding of quality specifications and process control levels, as well as the microbiology of water systems.
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Objectionable Microorganisms: Considering the Risk
Frank Settineri
90 Min
Product Id: 701313
This Objectionable Microorganism training will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
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Water System Compliance - Harmonizing Water Microbial Testing for Optimal Quality Control
T.C Soli
90 Min
Product Id: 701300
This water compliance training/webinar covers the reasons for diverse types of flora from one type of water to the next, the differences in the compendial water test methods, the advantages and disadvantages of harmonization.
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Water System Compliance - What Makes Water Systems Have Microbial Quality Problems
T.C Soli
90 Min
Product Id: 701283
This Water System Compliance training will review what biofilm is and how it grows and will cover how it affects just about every kind of unit operation used in today's water systems.
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Auditing and Compliance of Biopharmaceutical API Facilities
Frank Settineri
90 Min
Product Id: 701208
This FDA audit training will review the fundamental aspects of auditing biopharmaceutical API facilities to ensure their compliance with current regulatory guidelines.
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Validation of Rapid Microbiological Methods
Scott Sutton
90 Min
Product Id: 701240
This biotech training will look at different methods to validate the alternate method and Validating of Rapid Microbiological Methods.
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Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500
Jeff Odum
60 Min
Product Id: 701207
This Biopharmaceutical training will introduce and link the concepts of GEP and QbD and also identify synergies with the new ASTM E2500 standard Biopharmaceutical Active Pharmaceutical Ingredients (APIs) must be produced according to Good Manufacturing Practices outlined in FDA and ICH guidelines in order to be marketed to the public. This webinar will review the areas that an inspector may examine when conducting an audit of a biopharmaceutical API supplier to ensure it complies with regulatory requirements.
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Contamination Control 101 in Pharmaceutical, Biotech, and Medical Device Clean rooms
Jim Polarine
90 Min
Product Id: 701023
This Contamination-Control training will provide valuable assistance to companies that need to validate their cleaning and disinfection programs.
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Validating Disinfectants for Pharmaceutical and Biotech Operations
Jim Polarine
90 Min
Product Id: 701021
This Biopharmaceutical Compliance training provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Designing an effective disinfectant validation program to meet FDA and EMEA scrutiny. This webinar provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Current 483's, Warning Letters, and Field Experiences will be conveyed that allow end users to determine that best methods to validate their products against their isolates.