Course Scope
This course is aimed at key personnel working in management, QA, QC, production, engineering and clinical trials, who wish to have a broader and more extensive appreciation of pharmaceutical good manufacturing practices.
This stimulating course systematically builds up the knowledge of delegates over three intensive days. It covers the regulations and guidelines associated with GMPs and the expectations of the MHRA and FDA. Topics examined include incoming materials, including control of suppliers of APIs, excipients and packaging materials. Other sessions examine manufacturing, packaging, premises, equipment, engineering activities, quality systems and laboratory practices. The course is highly interactive and also features several real-life case studies.
Learning outcomes
By the end of the course you will:
- Be able to find your way confidently around the rules and guidelines of GMP
- Be able to find your way confidently around the UK ‘Orange Guide’, (which incorporates the EU Guide to GMP)
- Be able to find your way confidently around the FDA Code of Federal Regulations
- Have acquired a broad but comprehensive knowledge of GMP allowing you to speak and act with confidence in your work environment
- Have developed an understanding of the current GMP expectations and how to interpret and apply them in practical situations
