Curriculum

Virtual Manufacturing (GMP)

Virtual manufacturers in the life sciences industry are companies that do not own or operate physical manufacturing facilities. They rely on CDMOs (Contract Development and Manufacturing Organizations) to manufacture their products and CROs (Contract Research Organizations) to conduct necessary clinical trials. By outsourcing these core activities, virtual manufacturers can focus on product development, research, and marketing, reducing overhead costs and accelerating time-to-market.

Supplier Quality Management

Supplier Quality Management

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Good Documentation Practices (GDocP)

CAPA and Effectiveness Checks

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FDA Inspection Readiness (GMP Auditing)

General Inspection Readiness

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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

ICH Q9 – Quality Risk Management

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Good Pharmacovigilance Practices (GVP)

Recalls and Consent Decrees

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Good Manufacturing Practices (cGMP) - Intermediate

Regulatory Submissions

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Good Manufacturing Practices (cGMP) - Intermediate

Batch/Product Release

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Refresher Training

Data Integrity Refresher Course

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FDA Inspection Readiness (GMP Auditing)

How Self-Inspection Leads to Continuous Improvement

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Courses

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