Experts

Auditing and Compliance

Contact Center Expert: Michael J. Gregor is the founder of Compliance Gurus Inc., West Newbury, Mass. mgregor@compliancegurus.com.

Gregor has extensive experience in the biological, cosmetic, food, drug, healthcare, medical device and pharmaceutical industries.

During the past 17 years, he has gained significant experience in auditing, computerized systems validation, drug product, drug substance, expert witness testimony, FDA compliance, HIPAA compliance, IT systems implementation, laboratory instrumentation validation, manufacturing equipment validation and project management.

He has a B.S. in Business Management and a MBA with a concentration in information systems.

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Repackaging USP-grade Products
We are a chemical distributor and repackager, and do business with pharmaceutical companies that require USP-grade products. Where can one locate "acceptable repackaging guidelines" — for example, for packaging a USP-grade solvent in a 55-gallon drum?
Category: Auditing and Compliance

Syringe-filling compliance
What are the basic requirements to be in compliance for a syringe-filling operation? Where can I get more information?
Category: Auditing and Compliance