June Nothern Virgina Section 0511 Members' meeting - Join us as we discuss the Drug Development and Review Process on 10 June 2020
ASQ Section 0511 June 2020 Meeting Announcement
Wednesday, 10 June 2020
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Seema Garg MS, MBA, CQA, CSGB, Principal QA Auditor II, Technical Resources International, Inc.
Since there is so much interest in clinical research these days due Covid-19, I thought I could present the General Drug Approval process
Seema has worked in the Pharmaceutical and Healthcare Industry for 22 years in different areas like Research Laboratories, Diagnostic Laboratories and Clinical Research Organization as a Researcher, Manager and now as Principal QA Auditor II.
She is well versed on complex clinical trial regulations and guidelines of the Food and Drug Administration (FDA), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), International Conference on Harmonization (ICH), Good Clinical Practices (GCP), Human Subject Protection (HSP), European Medical Agency (EMA), College of American Pathologists (CAP) and Clinical Laboratory Improvement Act (CLIA).
Seema has significant experience in auditing Domestic and International Clinical Trials, and policies and procedures of government agencies like National Institute of Allergy and Infectious Diseases (NIAID), National Cancer Institute (NCI), Biomedical Advanced Research and Development Authority (BARDA), Division of AIDS (DAIDS) as well as National Institute on Drug Abuse (NIDA).
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- 5:00pm - 6:00pm Section Leadership Committee Meeting
- 6:00pm - 7:30pm Section Business & Presentation
Meetings are open to all ASQ members as well as to the public.
Wednesday, 8 July 2020 — TBD
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