WEBINARS

 

Blood and Blood Products Regulatory Compliance Training - Live Webinars, Recordings & CDs

Automating Assays for Clinical Diagnostics

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703268

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

Recording Available

 

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 703474

This webinar will enable participants to understand sources of contamination and to investigate various contamination issues in the biopharmaceutical manufacturing of sterile and non-sterile products. Learn how to create an effective Environmental Monitoring (EM) program.

Recording Available

* Per Attendee $249

 

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 705072

This webinar you will discuss how to help your organization get a better handle on what is an “objectionable microorganism, ” exactly how “objectionable” it really is and what you can do to minimize the risk if you find one in your process or product.

Recording Available

* Per Attendee $249

 

Understanding and Remediating Corrosion Problems during Parenterals Manufacturing

webinar-speaker   Barrett Rabinow

webinar-time   2 hrs

Product Id: 704983

In this two-hour webinar you will learn how to recognize problems related to corrosion, how to diagnose their specific causes, and how to remediate them. This webinar surveys the range of corrosion-mediated failure modes of parenteral solution manufacture. The roles of physical factors such as temperature, humidity, oxygen as well as formulation variables such as chloride level, pH, and inorganic metals will be discussed in this session.

Recording Available

 

Documentation Requirements for Master and Working Cell Banks

webinar-speaker   Debra Barngrover

webinar-time   60 Min

Product Id: 704030

This training program will prepare attendees for new regulatory requirements that will arise and apply to your cell line, even if it was made before the requirements were in place. One of the first steps in a recombinant project is the development of the cell line to produce the protein of interest, generally years before the product will be filed for licensure. How do you peer into the future to make sure that when the day comes to file for approval that you have collected and saved all the necessary information on that cell line and your master and working cell banks? Don’t make the mistake of assuming that you can find all that information years from now – create a plan to ensure everything is documented and saved.

Recording Available

* Per Attendee $229

 

FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

webinar-speaker   Mukesh Kumar

webinar-time   90 Min

Product Id: 703652

This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.

Recording Available

* Per Attendee $229

 

How To Translate Academic and Discovery Assays Into GLP Compliant Assays

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703275

This GLP compliant assay training will help attendees deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.

Recording Available

* Per Attendee $229

 

Life Cycle Validation of GMP Potency Bioassays

webinar-speaker   Ana Menendez

webinar-time   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.

Recording Available

* Per Attendee $229

 

Accelerating Bioassay Transfer in a GMP Environment

webinar-speaker   Ana Menendez

webinar-time   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.

Recording Available

* Per Attendee $229

 

Phase Specific Validation of Potency Bioassays

webinar-speaker   Ana Menendez

webinar-time   60 Min

Product Id: 701530

Learn the current regulatory guidances in USP1034 chapter of analyzing bioassays, and USP1033 chapter of bioassay validation and know how to take the potency bioassay from pre-clinical development throughout final commercial implementation.

Recording Available

* Per Attendee $50

 

Current Regulatory Requirements for Sterile Products

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 703672

This webinar will highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

Recording Available

 

 

 

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