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Today is Sep 5, 2010
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| March 17, 2004 |
| Time: |
12:00 PM to 1:30 AM |
| Topic: |
Investigational Site Quality: Signs and Symptoms of Questionable Compliance |
| Speaker: |
Liz Wool, RN,BN,CCRA & Greg Meyer, CQA, RAC |
| Speaker's Website: |
http://www.compliancemedia.com |
| Location: |
Gilead Sciences, Inc. |
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333 Lakeside Drive |
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Foster City, CA, California |
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Get Map and Directions |
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Liz Wool is Associate Director, Global Clinical Education and Training, at Gilead, Foster City, California. In her current position, Liz is responsible for SOP development, administration and employee training for GCP related departments. Liz possesses 24 years experience in health care organizations. Liz began her career as a Registered Nurse at Johns Hopkins Hospital, Baltimore, Maryland.. Lizs breadth of experience encompasses positions held in a government agency, a Contract Research Organization, as well as start-up biotechnology, biopharmaceutical and drug companies. She has developed SOPs for these various organizations which have addressed the needs of companies developing biologics, vaccines and drugs. She presented workshops entitled SOP Administration: Systems, Processes and Documentation and Getting the Most out of your SOPs at US industry conferences.
Gregory Meyer has been auditing and training organizations for clinical and manufacturing compliance for over 10 years. He began his career doing Emergency Medicine research at the University of California, San Francisco and has subsequently managed compliance and quality programs for drug, biotech and device companies including Chiron, Aradigm and Connetics where he was Director of Compliance overseeing GMP, GLP and GCP supplier qualification. He started Compliance Media to help create and support cultures of compliance in small molecule, biotech and medical device companies at all stages of development, clinical testing, licensed manufacturing and marketing. Compliance Media has performed compliance training and auditing for FDA regulated organizations in academia and industry since 1999. Greg has an RAC certification from the Regulatory Affairs Professionals Society and is an American Society for Quality Certified Quality Auditor.
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