About Sarah Wilson

Affiliations:

•Society of Clinical Research Associates (SoCRA)
•Society of Quality Assurance
•American Business Women’s Association
Association of Black Cardiologists

1. Research Quality: Handling Investigational Drug Products
   http://qualitytrialsip.onlineclasses.com
2. Research Quality: Protecting Research Subjects
   http://qualitytrials.onlineclasses.com

•Certified Clinical Research Professional (CCRP)- 2003
•MS Psychology, Chadwick University - 2002
•Certified cGMP Trainer - 2000
•Bachelor of Science, Claflin College - 1978

•Developed training session plans for subordinates, mid-level managers and executives
•Developed and provide training to medical doctors, nurses, physician assistancts and other medical personel as it relates to clinical research
•Performs cGMP training for Management, Support Staff, QC/QA, and Maintenance
•Perform cGMP/ISO-9000 training.
•Teach basic chemistry to perspective employees.
•Manage clinical research auditors and documentation personnel.
•Provide investigator onsite GCP training.
•Assist domestic and foreign investigator site's staff with regulatory agency inspections, Assist investigator sites with answering regulatory findings, FDA-483’s and Warning Letters where applicable.
•Interact with senior management and CEO to convey company compliance status.
•Provide training to permanent employees including mid and senior level managers.
•Review documentation submission for ICH and regulatory compliance. Write and review SOPs, Work Instructions and other procedures applicable to regulated entities.
•Oversee and manage cGMP, cGCP and cGLP Quality Systems as applicable to company's needs.
•Coordinate and approve SOP and work instruction processes.
•Manage and approve QA expenditures.
repare audit schedule.

ABWA Woman of The Year Nominee
ABWA Longterm Member Inductee
Leadership Awards

•June 19, 2007, Investigators Hosting FDA Inspections –Things to Consider, DIA 42nd Annual Meeting
•October 10, 2006, Investigator Meeting Presenter: GCPs and the Investigator’s Research Commitments, N2 Clinical Research
•September 23-25, 2005 Session Speaker: Embracing The Sponsor Audit and Minimizing Risks in Clinical Trials, SoCRA Annual Conference
•June 1-4, 2004: Poster Session Co-Author: Achieving Compliance in a Sponsor-CRO Collaboration, DIA Annual Meeting
•August 2003, Organized and Implemented Georgia's local SoCRA Chapter
•October 14-18, 2002: Poster Session Author: Drug Manufacturing From An Auditor’s Perspective, SQA Annual Meeting
•October 08-12, 2001: Poster Session Author: GMP Training and The Forgotten Asset, SQA Annual Meeting
•October 09-13, 2000: Poster Session Author: GxP Makes Good Business Sense, SQA Annual Meeting