Empowering professionals for over 24 years

Empowering professionals for over 24 years

cGMP PRIMER | CPE

cGMP PRIMER | CPE
  • Level: Intermediate
  • CPE: 1 Credits
  • Time: 50 Minutes

cGMP Primer examines six pillars of compliance—from quality systems to materials and training—that ensure drugs are manufactured in accordance with global regulations and standards. Learn how regulatory audits, Establishment Inspection Reports (EIRs), and 483 remediations shape risk and reputation.

  1. Explore the fundamental principles of cGMP
  2. Gain insight into the challenges of achieving cGMP compliance across global regulatory environments
  3. Learn the best practices for implementing Quality Management Systems
  • Best Value: Unlimited Learning
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  • Up to 12-month unlimited access
  • Content designed for all skill levels: Beginner to Advanced
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Get full access to this course with a one time purchase.

  • 1-month access to all course material
  • CPE credits included
  • No subscription required
  • Self-paced and on-demand
  • Ideal for focused, one-off learning
  • Overview
  • Agenda
  • Features
  • Justify This Training
  • FAQ

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Agenda

  1. Understanding cGMP

    Details the role, rationale, and importance of global current good manufacturing practices (cGMP) for drugs, medical devices, and blood.

  2. cGMP Pillars 1-3

    Explains the roles and rationale of cGMP compliance, covering quality management systems (QMS), premises and equipment, and personnel training.

  3. cGMP Pillars 4-6

    Explores the roles and rationale of cGMP compliance, covering materials management, documentation and records, and validation and qualification.

  4. cGMP Non-Compliance

    Outlines how regulatory audits, establishment inspection reports (EIRs), and 483 remediations shape risk and reputation.

Features

  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Course materials
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates

Justify This Training

View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.

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