ComplianceOnline

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

Automating Assays for Clinical Diagnostics
11
/ Dec
Wednesday-2019

Automating Assays for Clinical Diagnostics

  • Speaker: Todd Graham
  • Product ID: 703268
  • Duration: 60 Min
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.
* Per Attendee
$229
Recorded/CD
Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

  • Speaker: Henry Urbach
  • Product ID: 703474
  • Duration: 90 Min
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.
CD/Recorded
$249
Recorded/CD
Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

  • Speaker: Henry Urbach
  • Product ID: 705072
  • Duration: 90 Min
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.
CD/Recorded
$249
Recorded/CD
Understanding and Remediating Corrosion Problems during Parenterals Manufacturing

Understanding and Remediating Corrosion Problems during Parenterals Manufacturing

  • Speaker: Barrett Rabinow
  • Product ID: 704983
  • Duration: 2 hrs
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.
Recorded/CD
Documentation Requirements for Master and Working Cell Banks

Documentation Requirements for Master and Working Cell Banks

  • Speaker: Debra Barngrover
  • Product ID: 704030
  • Duration: 60 Min
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.
CD/Recorded
$229
Recorded/CD
FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

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

  • Speaker: Mukesh Kumar
  • Product ID: 703652
  • Duration: 90 Min
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.
CD/Recorded
$229
Recorded/CD
How To Translate Academic and Discovery Assays Into GLP Compliant Assays

How To Translate Academic and Discovery Assays Into GLP Compliant Assays

  • Speaker: Todd Graham
  • Product ID: 703275
  • Duration: 60 Min
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.
CD/Recorded
$229
Recorded/CD
Life Cycle Validation of GMP Potency Bioassays

Life Cycle Validation of GMP Potency Bioassays

  • Speaker: Ana Menendez
  • Product ID: 702195
  • Duration: 90 Min
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.
CD/Recorded
$229
Recorded/CD
Accelerating Bioassay Transfer in a GMP Environment

Accelerating Bioassay Transfer in a GMP Environment

  • Speaker: Ana Menendez
  • Product ID: 700374
  • Duration: 60 Min
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.
CD/Recorded
$229
Recorded/CD
Phase Specific Validation of Potency Bioassays

Phase Specific Validation of Potency Bioassays

  • Speaker: Ana Menendez
  • Product ID: 701530
  • Duration: 60 Min
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.
CD/Recorded
$25
Recorded/CD
Current Regulatory Requirements for Sterile Products

Current Regulatory Requirements for Sterile Products

  • Speaker: Kenneth Christie
  • Product ID: 703672
  • Duration:
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.
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