Why Should You Attend:
During product development, many experimental CMC studies to support process development and product characterization are conducted in non-GMP laboratories, including academic and contract facilities. However, the data generated in these studies may be utilized in product regulatory filings, making them subject to concerns about traceability and reproducibility. While there are no formal compliance requirements for R&D laboratories, emerging regulatory concepts in quality systems and quality by design place greater compliance pressure on R&D labs for sound scientific practices. Additionally, early-phase quality control testing may be performed in laboratories that are not fully GMP compliant, and are in fact much closer to R&D than GMP.
Areas Covered in the Seminar:
Who Will Benefit:
This webinar is for anyone associated with generating, reviewing, utilizing or contracting analytical studies for pharmaceutical product development.
Nadine M. Ritter,Ph.D., senior consultant for Biologics Consulting Group, Inc., is a protein chemist with expertise in the chemistry, manufacturing and control (CMC) of biotechnology products. She is past Director of Analytical Services Division at major contract testing organization performing R&D, GLP and GMP analytics studies. For over 15 yrs, she has contributed data to numerous US and international regulatory IND/IMP and BLA/NDA/MAA filings. Nadine also has considerable experience conducting audits of sponsor and contract laboratories worldwide. She is a member of several professional analytical organizations, and is frequently invited as a speaker and writer on analytical and stability issues.
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