Differences in GMP Requirements between Drugs and Biologicals
Instructor:
Steven S Kuwahara
Product ID: 700872
- Duration: 60 Min
While biologics must follow the same GMP regulations as those that apply to small molecule drugs, there are additional GMP regulations that apply to biologics alone. The current transfer of "specified biologics" to the Center for Drug Evaluation and Research (CDER) has created some confusion over their regulation. Gene and Cell Therapies have also created some confusion as well as new requirements that apply to these types of biologics. This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes.
Areas Covered in the seminar:
- Definitions of types of biologics and the special classes of biologics.
- Regulations that apply to biologics in general.
- The situation with "specified biologics."
- Regulations that apply to gene and cell therapies.
- Changes in the emphasis of the GMPs when considering biologics.
Who will benefit:
This webinar will be directed at workers with some experience who must now deal with the manufacturing of various biological products. This is especially important for workers who must deal with different types of products while being employed at a single company.
- Manufacturing workers and supervisors who will produce biological products.
- QA and QC workers who must develop testing and monitoring programs for biological products.
- Regulatory affairs personnel who must prepare CMC sections and verify the compliance of their manufacturing operations.
- Auditors who must review the activities of biological product producers.
- Consultants
Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, and in performing GLP and GMP audits of internal and external testing laboratories. He began his career in companies that produced biologic products and has continued to work with biologics and the gene and cell therapy industries.
More Training By Experts
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- Monoclonal Antibodies and Therapeutic Proteins: Designing GLP Compliant Nonclinical Programs to Meet FDA Expectations
- Quality Expectations for Product Development CMC Activities: R & D, GLP or GMP
- Small GMP problems which cause the biggest enforcement headaches: how to tackle them
- Learning from Laboratory-related FDA Warning Letters
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