Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500

Instructor: Jeff Odum
Product ID: 701207
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

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.

Areas Covered in the seminar:

  • Review of applicable regulatory guidelines that oversee the manufacturing of Biopharmaceutical APIs.
  • What are the GMP requirements I need to know?
  • What are the specific guidelines for APIs manufactured by cell culture/fermentation?
  • What are the requirements for cell bank maintainence and record keeping?
  • What are the requirements for cell culture/fermentation?
  • What are the requirements for harvesting, isolation and purification?
  • What are the requirements for viral removal/inactivation steps?

Who will benefit:

This webinar will benefit project teams that are facing new capital projects that must focus on meeting FDA scrutiny for meeting qualification and validation expectations.
  • End users
  • Engineering service providers
  • QA personnel
  • Regulatory compliance specialists
  • Quality system auditors.
  • Consultants.

Instructor Profile:
Jeff Odum, has been involved in the biopharmaceutical industry for more than 20 years. He is a nationally recognized author and speaker who provide industry insight in the areas of regulatory compliance, facilities and process design, and project management for biopharmaceutical companies. These companies develop facilities that are focused on the development and manufacturing of regulated products for the consumer industry.

Jeff’s experience in the biopharmaceutical industry has included design and construction of many of the industry’s major manufacturing projects, as well as consulting roles for a number of the global biotechnology industry leaders. These projects represent a total capital investment of well over $2 billion dollars and produce many of the key biopharmaceutical therapeutics and vaccines currently in the marketplace.

Jeff is the author of more than 30 published works on many critical issues, including process improvement and execution to meet regulatory guidelines issued by the FDA and other international regulatory bodies. These works include three books that are recognized industry reference guides, including Sterile Product Facility Design and Project Management (CRC Press).

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