Good Manufacturing Practice [English]

GMP (Good Manufacturing Practice) offers guidelines for quality assurance in the production of pharmaceuticals.

Knowledge of GMP is often a crucial requirement when applying for industry jobs, especially in the pharmaceutical sector. This GMP basic course focusses on topics that will be applicable to their industry position. Additionally, you get the chance to come into contact with prospective employers.

After successful examination the attendees receive the GMP certificate, issued by the certified educational provider "Thomas Beer & Tobias Halfpap GbR".

LinkedIn event: https://www.linkedin.com/events/6885936738666106881

If you are interested, please register via our online form.

Schedule:

07.03.2022:

• 8:30-9:00: Introduction to GMP basic Course
• 9:00-10:30: German GMP-Regulations & Medical Devices
• 10:45-12:15: European & American GMP-Regulation Guidelines
• 13:15-14:45: GMP-Guidelines of ICH
• 15:00-16:30: Good Distribution Practice
  

08.03.2022:

• 9:00-10:30: Chapter 4 - EU-GMP-Guideline Documentation
• 10:45-12:15: ICH Q2 Validation of Analytical Methods; Qualification
• 13:15-14:45: GMP Statistivs - Basics
• 15:00-16:30: Statistical Applications in Drug Industry

09.03.2022:

• 9:00-10:30: Annex 15 EU-GMP-Guideline Qualification and Validation
• 10:45-12:15: Chapter 5 EU-GMP-Guideline Production
• 13:15-14:45: Chapter 2+3 EU-GMP-Guideline Personnel, Permises and Equipment
• 15:00-16:30: Pharmaceutical Packing

10.03.2022:

• 9:00-10:30: Annex 8 EU-GMP-Guideline a. o. Sampling, ICH Q6 Specifications ICH Q1 Stability Test
• 10:45-12:15: Chapter 6 EU-GMP-Guideline Quality Control
• 13:15-14:45: Good Clinical Practice (GCP)
• 15:00-16:30: Good Laboratory Practice (GLP)

11.03.2022:

• 9:00-11:00: Information Event about Application in Industries and their Processes

Final exam: Wednesday, 16.03.2022, 4.00 - 5.00 p.m.