CGMPs for Investigational Drugs and Biologics

Instructor: Barbara Immel
Product ID: 700234
  • 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
Last Recorded Date: Jun-2007

Training CD / USB Drive

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

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

The European Union has stated their requirements in Annex 13, while FDA has recently issued a controversial new phase 1 guidance


Join us for a discussion of actual requirements, and both historic and current guidance document recommendations

Why Should You Attend:

In the recent past, there have been several high-profile patient injuries and deaths in phase 1 human clinical trials. Investigational drugs and biologics must be manufactured per current good manufacturing practices (CGMPs). Although it is understood that as product development proceeds from early to late stage clinical trials, the stringency with which CGMPs must be followed increases, sterile drugs must be proven sterile before clinical trials may begin, and for biologic products, the aseptic processing and necessary viral clearances, etc. must also be proven before introducing the product into people.

Areas Covered in the seminar:

Regulatory requirements to manufacture investigational drugs and biologics for the U.S. and European Union:

  • Highlights of recent FDA guidance documents
  • Recommendations in earlier FDA guidance documents
  • Practical issues
  • "Must haves"
  • Where you can get more information; recommended resources and clinical trial material groups

Who Will Benefit:

This session will benefit industry professionals, managers, and scientists working in:

  • Quality assurance/quality control
  • Research and development
  • Manufacturing
  • Process development
  • Regulatory affairs
  • Clinical operations

Instructor Profile:

Barbara Immel, For more than 24 years has been one of the most listened-to voices in the regulatory field. As president of Immel Resources LLC, she helps pharmaceutical, biologic, and medical device companies improve their compliance track records. She specializes in management consulting for regulatory compliance, quality assurance, and training. A gifted public speaker, she is also a well-respected writer, with more than 50 published articles to her credit. She is also editor of the Immel Report, a subscription newsletter providing advice and guidance for managers in FDA-regulated industry.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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