Module 12 2019

Guidance

Retention & Archiving of Study Materials & process records, raw data & source data critical part of compliance and regulatory Compliance

• Good Laboratory Practice (GLP)

• Good Clinical Practice (GCP)

• Good Manufacturing Practice (GMP)

Pharmacovigilance (PV)

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• 21CFR Part 11 – electronic records & signatures

Financial requirements

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• Other business critical needs..

The Organisation for Professionals in Regulatory Affairs