Quality Practices for Research and Development (R&D) CMC Laboratories

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.

• A large number of CMC studies to support product development are not required to be performed in GMP laboratories.
• Data from supportive CMC studies are typically presented in regulatory dossiers which makes them subject to later review and verification.
• Lack of adequately documented early development data often becomes a cost factor for in-licensed products.
• Quality practices at academic and contract testing laboratories can greatly impact the utility of their CMC data.
• Some analytical laboratories erroneously interpret GLP as 'GMP-light'.

Areas Covered in the Seminar:

• What is the economical impact of poor quality R&D CMC data in product development timelines and costs?
• What laboratory studies are required to be performed under GLP vs GMP?
• What quality practices are expected for non-GMP/non-GLP laboratories where the data generated are used in regulatory filings?
• What are the key-process related CMC activities.
• what are Key Analytical and QC CMC Activities.
• what is good CMC practices and how to ensure CMC quality is consistently implemented.

Who Will Benefit:

This webinar is for anyone associated with generating, reviewing, utilizing or contracting analytical studies for pharmaceutical product development.

• Laboratory Directors and Personnel
• QA Managers and Auditors
• Regulatory Affairs CMC Specialists
• Contract Industry and Academic Testing Facilties
• Internal R&D Laboratories
• Project Managers with CMC Oversight

Instructor Profile:

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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