Good Manufacturing Practice training
Our GMP training course is a fully comprehensive two day training event set at either at a basic level or a more experienced level suitable for GMP professionals including QA/QC, Production and Regulatory personnel. This can be given either remotely or on site.
Our GMP training course covers the latest updates to the Orange Guide 2022 and HMR 2012 and provides multiple scenarios including personnel training prior to any regulatory inspection.
Our GMP training course can be tailored to your company requirements.
Good Manufacturing Practice training course Contents
The course is structured in accordance with the Orange Guide and will discuss each chapter, what they mean and how to stay compliant with their requirements.
Topics covered will include:
- Quality Management
- Quality system
- Management review and monitoring
- Quality risk management including Failure Mode and Effects Analysis
- Qualified Person
- Other personnel
- Premises and Equipment
- Documentation and Control
- Cross contamination prevention
- Receipt of starting materials
- Quality Control
- Stability studies
- Data integrity
- Outsourced Activities
- Types of activities
- Service Provider audits and monitoring
- Technical Agreements
- Complaints, Defects and Medicinal Product Recalls
- How to undertake an investigation
- Risk Assessment
- Root Cause Analysis
- Audit planning
The courses are interactive and include a variety of workshops to stimulate debate and bring real life situations into play.
In addition we will cover Annexes 1 to 21 and how they relate to your company. If required we can also provide a specific training session for Part 2 (API), Part 3 (PQS) and Part 4 (ATMP).
By the end of this interactive course you will be able to:
- Describe the importance of Good Manufacturing Practice and why you need to comply
- Understand the latest UK GMP
- Understand and have a comprehensive knowledge of the Roles and Responsibilities of the Qualified Person (QP)
- Identify controls necessary to maintain compliance
The GMP training course is available throughout the year.
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation, please send your request to firstname.lastname@example.org or schedule a free initial telephone consultation by phoning 07880 187746.
Interested in our GMP Training?
Everything we do is tailored to the customer, contact us to see how we can help you with your GMP training.
Flexible Training & Services
Our services and training can be tailored to your exact needs. We understand that within the pharmaceutical industry, there is no such thing as a ‘one size fits all’ solution to services such as GMP training.
Let us know your requirements and we can create the perfect, custom solution for you.