Good Manufacturing Practice – Advanced
Looking to gain in-depth Good Manufacturing Practice (GMP) knowledge while building the practical skills essential for ensuring product quality, patient safety, and regulatory compliance?
This course systematically builds up your knowledge through a series of in-depth interactive sessions covering essential aspects of GMP compliance, including managing incoming materials, manufacturing, packaging, premises, equipment, engineering activities, quality systems and laboratory practices.
Exploring regulations and guidelines associated with GMP, this course features several real-life case studies ensuring you gain practical insights which can be effectively applied in your everyday work environment.
Key Topics
This course covers the following topics:
- Introduction to Pharmaceutical Quality Systems
- Handling contracting out, complaints and recall procedures
- Conducting audits and self-inspections
- Validation and qualification
- Different classifications of GMP documentation and application
- Out of Specification (OOS) reporting and investigation
- Good Quality Control Laboratory Practices (GQCLP) under GMP
- Deviations and investigations
- Control of supply chain
- Premises, and equipment requirements
- Control of incoming materials
- Key personnel roles and training
- Change management
- ICH Q9 principles
- GMP in the USA
- How to use the Orange Guide
- UK legislation and licensing for human and veterinary medicines and relationship to EC/EU directives
- Approach to GMP in ensuring patient safety
- Role of UK MHRA in licensing and inspection
Learning Outcomes
This course will enable you to:
Who should attend?
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 GMP and its application.
Register Interest in Life Science Training
Use the form below to register your interest in our RSSL Life Science training courses. Please select the course you are interested and we will be in touch with more information on dates and costs etc.