Overview
This course is aimed at managers, supervisors and technical staff working engineering departments and support functions in the pharmaceutical industry. It will assist them in understanding and applying relevant Good Pharmaceutical Practice (GxP) principles to practical workplace situations.
The development of the rules and guidelines of GxP will be discussed with the delegates, who will go on to establish the implications and potential risks to product safety which can result from engineering activities and the steps that must be taken to ensure regulatory compliance.
A hands-on, practical approach is taken with the course and the delegates learn through accessing the various rules, regulations and guidelines as they work through a series of
Key Subject Areas
- Introduction & History of GMP/cGMP in pharmaceutical/biopharm Industries
- Current regulatory thinking – risk management
- QA/QC issues associated with engineering activities
- Documentation
- Contamination control
- Validation
- Self Inspection (Internal audits)
Course Objectives
The objectives of the course are that delegates will:
- Understand the regulatory requirements and constraints facing engineering groups in the pharmaceutical industry
- Become familiar with the relevant sections and clauses of the ‘Orange Guide', FDA CFRs, FDA Guidance for Industry series and various industry guidance documents and web sites – in particular, the aim is that the delegates will know where to go to source information relating to various issues and challenges.
- Develop their departments process and identify the controls necessary to ensure compliance with GMP/GxP regulations and guidelines
Who Should Attend
Engineering managers, supervisors and technical staff - both front-line and support functions - will benefit from this course.
To ensure the effectiveness of the practical sessions, the number of delegates is limited to a maximum of 15.
Duration
3 days
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. The course includes a number of case studies where delegates are asked to work in small groups to solve problems and concludes with a short quiz to test the delegates' comprehension of the subject.
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.
