START2PHARMA: cGMP & QMS Essentials

Content

Join our comprehensive cGMP and QMS training and gain a solid understanding of the essential principles behind Good Manufacturing Practices and Quality Management Systems. Discover how these practices are crucial for ensuring product quality and compliance in highly regulated environments. This training will provide you with practical insights into how to implement and maintain quality standards while exploring the role of authorities, legislation, and inspections. Complementing your company’s internal processes, the training offers a strategic overview and valuable background information.

Added Value

This training enables participants to understand the broader framework beyond the basics learned within their company. During this training, participants will have a final test to assess their understanding of basic GMP principles.

Training Topics

Day 1:

  1. GMPs for Pharmaceuticals
  2. Why GMP
  3. GMP Regulations and Guidelines
  4. Expectations of FDA & European Inspectors
  5. Other Key Standards: ICH, PICS, GAMP
  6. Exercises on General and Specific GMPs
  7. Data Integrity (ALCOA)​

Day 2:

  1. QMS
  2. Training and Personnel Competency
  3. Document Management System
  4. Good Documentation Practices (GDP)
  5. Asking Questions When Unsure
  6. Reporting Deviations
  7. Contamination Control

Objectives

  • Understand the basics of GMP and its application in the pharmaceutical industry.
  • Learn key GMP regulations and guidelines (ICH, PICS, GAMP).
  • Gain knowledge of the requirements for an effective QMS and document management systems.
  • Comprehend the principles of Data Integrity (ALCOA) and Good Documentation Practices (GDP).
  • Understand the importance of GMP for ensuring safe and effective drug production.
  • Recognize the differences in GMP requirements across markets and the expectations of
    inspectors.
  • Learn how to report and handle deviations effectively to maintain product quality.
  • Understand and apply contamination control measures in pharmaceutical production.

Target Group

  • New employees in the pharmaceutical industries
  • Quality managers and quality staff
  • Production personnel
  • Regulatory affairs staff
  • Auditors
  • Supplier employees

Methodology: The training method combines theory, questions, exercises, and case studies, with a test at the end of Day 1 to assess understanding of GMP.

Duration: 2 days

Fee: €995 per person for the 2 days

Participants: Min 5 & Max 10

Place: Niel or On-site

Language: Dutch/French/Eng

Registration Form

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