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Mock FDA Audit, SDLC, Bood
Conducted Mock FDA Audits of Device Development, Blood Operations and Software as a Medical Device for Large Biologics Manufacturer |
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During my time as the Sr. Director in charge of Quality System Management for Information Systems at our National Headquarters, Mr. Bacchus conducted a quality system audit of our department. This was at a very busy, tense and political time for our organization in the area of compliance. Mr. Bacchus was part of a team, with his specific role being the Information Systems department. I found Mr. Bacchus to be very knowledgeable of FDA regulations, quality standards, and industry practices. He understood not just the words of the regulations, but also the quality reasons and goals behind them. During the audit, Mr. Bacchus was respectful of staff and exhibited patience, making the audit experience also an education experience for all staff members who interacted with him. His diplomacy ultimately gained him more information, and therefore gained our organization a more useful audit. Mr. Bacchus is also very organized, methodical and thorough. If I challenged his understanding of a regulation, he was respectful of that challenge and would do the homework required to support his understanding. I recommend Mr. Bacchus of BEQS for his knowledge and approach to his work, and would hire his services again if the occasion arose |
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