GMP COURSE CONTENT
> History of GMP
> Regulations of GMP
> Your GMP Responsibility
> Quality Commitment
> GMP Basics: Data Integrity, Documentation, Qualification/Validation, Training, Hygiene, Cleaning
> Deviation and CAPA Management
> Out of Specification (OOS), Out of Expectation (OOE) and Out of Trend (OOT)
> Complaint Handling
> Change Control
> Regulatory Process – Product Lifestyle
> Inspections and Audits
> GMP Violations
> Potential Consequences of Failure to Comply
> QUALITY starts with YOU!
ASSESSMENT
Continuous assessment
CERTIFICATION
current Good Manufacturing Practices (cGMP)
TRAINER
Highly experienced having previously held the post of Learning & Development Manager for two of the top 10 global pharma companies (Novartis and Eli Lilly & Co).
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