Audit - 1 Day Onsite All Inclusive - U.S. 210 Part 11 - Electronic Records/Electronic

Part 11 - Electronic Records/Electronic Signatures (ERES)

Guidelines for good clinical practice (2005/28/EC)

Standard Sterile Product Manufacturing Handbook

Call for details

Canadian Medical Device Regulations - Last Amended on February 22

Audit - 1 Day Onsite All Inclusive - U.S. 210 Part 11 - Electronic Records/ElectronicTurnkey Audits & Training includes Airfare, Travel Rates, Hotel, Expenses & Reports (1 Draft & 1 Final). GMP Audits Drug, APIs, Excipients (DS DP) Medical Devices Part 820 QMSR ISO 13485 Supplier Audits, CMOs, CDMOs, CROs, Systems Laboratory Audits GLP GCLP, Part 58 OECD 21 CFR Part 11 Compliance & Validation Audits Cosmetics GMP Audits & Certificates Dietary Supplement GMP Audits & Certificates Clinical, CROs, GCLP, Investigator Sites Audits 503b