GMP for QC technicians

The course reviews the new GMP trends and guidelines in QC, with special emphasis on requirements for chemical and microbiological quality control during drug manufacturing. The course is based on both requirements from the FDA and the EU, and where there are differences, these will be addressed.

Course content

• Requirements for QC staff – training and education
• Handling of samples, chemicals, reagents and standards
• Data integrity and handling of raw data
• Managing OOS results (outlier results)
• Trends in FDA Warning Letters relevant to QC
• New guidelines from EMA and FDA, e.g. update of EU GMP Part 1, Chapter 6 on QC and USP <1117> (Microbiological – Best Laboratory Practices)

Pedagogical goal – to increase the knowledge of:

• To increase the laboratory technician’s knowledge of the regulatory requirements within GMP with a specific focus on QC
• Trends in GMP for QC
• Get acquainted with the most common terms used in the validation of analytical methods
• Refreshing general requirements for documenting data
• Understand and define different terms used and be able to navigate applicable legal texts and guidance from authorities

Who should participate:

• Persons working in QC in GMP regulated activities
• Persons who scrutinise or approve QC documentation, such as QA

Need for prior knowledge:

• You must have completed the GMP Basics course or have equivalent knowledge from working in the pharmaceutical industry
• You must have worked for a while with GMP/QS regulated activities so that you have some knowledge of the company.
• It is an advantage if you have any experience in quality control work

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