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Mock FDA Audit, SDLC, Bood
Conducted Mock FDA Audits of Device Development & Manufacturing and Blood Banking Operations. Audit development and validation of Software as a Medical Device and operational and quality system software for nation’s largest blood supplier. |
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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. Paul was part of a team, with his specific role being the Information Systems department. I found Paul 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, Paul 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. Paul 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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