June Nothern Virgina Section 0511 Members' meeting - Join us as we discuss the Drug Development and Review Process on 10 June 2020 1961
June Nothern Virgina Section 0511 Members' meeting - Join us as we discuss the Drug Development and Review Process on 10 June 2020
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ASQ Section 0511 June 2020 Meeting Announcement

Wednesday, 10 June 2020

Online Meeting

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Drug Development and Review Process
Presented by
Seema Garg MS, MBA, CQA, CSGB, Principal QA Auditor II, Technical Resources International, Inc.

Seema Garg


Short Narrative/Description:
Since there is so much interest in clinical research these days due Covid-19, I thought I could present the General Drug Approval process

Speaker Background:

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).

Date & Time
Wednesday June 10th, 2020 6:00pm CDT
End Date & Time
Wednesday June 10th, 2020 7:30pm CDT
Venue
Online
Categories
Meeting
Host Type
Geographic
Webinar Link / Meeting Instructions

Meeting Information:

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Reservations: There is no charge to attend. To register, please use our on line reservation form which can be used up to the day of the meeting. If your plans change, please contact dba20@asq0511.org, and let us know.

Additional Information

Schedule:

Meetings are open to all ASQ members as well as to the public.

Next Meeting:
Wednesday, 8 July 2020 — TBD

Call for Speakers!!!
Would you or someone you know like to speak at a future ASQ meeting? We're always looking for volunteers. Be creative! Exercise your public presentation skills! Earn recertification credits! Get a free dinner! Please contact programs20@asq0511.org.

Category Public Calendar

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