Kelmac I Group, Inc

Kelmac I Group, Inc

Process Validation Training Course



An intensive two-day training course on how to establish and improve compliance with the GMP requirements for process validation. Both the FDA Quality System Regulation, 21 CFR Part 820, and ISO 13485:2003 include requirements for process validation. In many cases manufacturers have not satisfactorily established compliance with the requirements in relation to process validation and have received adverse FDA inspections, including issuance of Warning Letters and Import Alerts. The course is designed to ensure delegates fully understand the essential business and regulatory requirements for

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