CGMPs for Investigational Drugs and Biologics

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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