ASQ Section 0511 April 2016 Meeting Announcement

Wednesday, 13 April 2016

updatedFiona's Irish Pub, Kingstowne Center

updated35810 Kingstown Center, Kingstowne, VA 22315

updatedDirections to Fiona's Irish Pub in Kingstowne Center

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Compliance Challenges in Clinical Research Naive Locations:
Case Study -- STRIVE (Sierra Leone Trial to Introduce a Vaccine against Ebola)

Seema Garg, MS, MBA, CQA, CSGB, Manager, Quality Assurance , Technical Resources International, Inc.

Seema Garg

Short Narrative/Description:

Speaker Background:

Seema has worked in the Pharmaceutical and Healthcare Industry for 18 years in different areas like Research Laboratories, Diagnostic Laboratories and Clinical Research Organization as a Researcher, Manager and now as Quality Assurance Manager.

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).

Handouts:

Dinner Location:

Fiona's Irish Pub is built on the rich Irish Spirit that makes a gathering place feel like home. It's authenticity is accentuated by the fresh, original dishes from the proprietor's hometown - Dublin, Ireland. Be sure to review the sample menu

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Reservations: Cost for dinner is $30.00 per person if reservations are made by the deadline (the Friday before the meeting), $35 if otherwise. There is no charge to attend for the presentation only. To register with or without dinner please use our on line reservation form which can be used up to the Sunday before the meeting. If you wish to make a reservation after the Sunday before the meeting or your plans change, please contact dba16@asq0511.org, and let us know.

Schedule:

5:30pm - 6:30pm Monthly Board Meeting
6:30pm - 7:00pm Registration & Networking
7:00pm - 8:00pm Dinner
8:00pm - 9:00pm Section Business & Presentation

Next Meeting:
Wednesday, 11 May 2016 -- 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 programs16@asq0511.org.