Overview
This is a new programme designed specifically for staff working in companies supplying Active Pharmaceutical Ingredients (APIs) to the Pharmaceutical Industry. It will assist them in understanding and applying Good Manufacturing Practice (GMP) principles to practical workplace situations.
The development of the rules and guidelines of GMP will be discussed with the delegates, who will then go on to investigate the implications, potential risks to product safety and the control systems in place within their organisation. By relating these findings back to the organisation's quality system, the delegates discover how quality is an integral part of their business.
The course concludes with a case study to allow the delegates to put their learning into practice.
Key Subject Areas
- Quality Management
- Personnel
- Premises & Equipment
- Documentation
- Production and In-Process Controls
- Materials Management, Storage and Distribution
- Sampling and Testing
- Validation
- Change Control
- Self Inspection (Internal Audits)
Course Objectives
The objectives of the course are that delegates will:
- Understand the regulatory requirements and constraints facing suppliers of Active Pharmaceutical Ingredients
- Become familiar with the relevant sections and clauses of the ‘Orange Guide' and the European and international guidelines and directives
- Develop their organisation's process and identify the controls necessary to ensure compliance with GMP regulations and guidelines
- ‘Close the loop' by linking regulatory requirements to Quality Procedures (ISO 9000) and everyday working practices
Who Should Attend
The course has been written so as to be interesting and engaging to operators, but it is appropriate to all levels within the organisation that might have an impact on product quality.
Duration
1 day
Course Format
The course is presented in-house using a balanced mix of presentations and practical sessions, where delegates will be encouraged to learn by self and group discovery. A short quiz is included to test the delegates' comprehension of the subject and the course concludes with a case study where they are asked to work in small groups to solve a problem.
Customisation
A significant proportion of the training course focuses on the client's own operating methods and quality procedures. The Quality Procedures Manual is used in the exercises.
Presenters
SeerPharma will lead the course and facilitate the group activities. The presenters used have many years experience working in the pharmaceutical industry and are able to add many anecdotes and real examples to the course material. Each of the presenters has extensive experience in training and facilitating groups in this type of course.
Course Materials
Delegates will be given a manual containing copies of the slides, accompanying notes and other relevant information.
Following the successful completion of the course, each delegate will be presented with a certificate.
