Quality Aware Cont.

Have: Written simple short-answer and fill-in-the-blank tests for CGMP regulations for Finished Pharmaceuticals. Trained Laboratory Personnel in all aspects of quality. Audited contract laboratories and manufacturing facilities for GMP compliance. Starting in 1989, have performed foreign pre-FDA audits of facilities in Nanjing, Shanghai, Haimen, Nantong, Jaijong, and Han Zhou (The Peoples Republic of China) and overseen the creation of Type I and Type II Drug Master Files as well as responses to FDA observational letters in the active pharmaceutical ingredients (API) area.

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FDA Aware Cont.

Able to elicit cogent answers from the Head of Foreign Inspections concerning the GMPs for APIs and BPCs, in general, and the impact on foreign inspections, in particular. Have provided formal scientifically sound and appropriate written input to the FDA on a wide variety of technical and regulatory matters.

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