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- Annex 15 Qualification and Validation
The GMP 210/211 regulations address issues including recordkeeping
Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
210/211 & 820 Pocket Guide
503b Outsourced Facility Qualifications
Audit - 2 Day Onsite All Inclusive - U.S. ISO 13485 - Annex 15 Qualification andTurnkey 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
