Standard Sterile Product Manufacturing Handbook
The Sterile Product Update with Annex 1 & ICH Q7
Optional EU Annex 14 - Manuf
Guideline for the Monitoring of Clinical Investigations
Part 1301 - Sections 71-77 Security and Sections 90-93 Employee Screening
Audit - 3 Day Onsite All Inclusive - U.S. DEA Standard Sterile Product Manufacturing HandbookTurnkey 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