Industry field:
Pharmaceutical and biopharmaceutical industry
Course description:
This course is aimed at managers, supervisors and technical staff working engineering departments and support functions in the pharmaceutical industry and external suppliers. It will assist them in understanding and applying relevant Good Pharmaceutical Practice (GxP) principles to practical workplace situations.
The difference between GEP and 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 to 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)
Learning 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 EU 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 operation's process and identify the controls necessary to ensure compliance with GMP/GxP regulations and guidelines and the application of GEP.
Who should attend:
Engineering managers, supervisors and technical staff - both front-line and support functions - will benefit from this course.
To request further information on this course or to reserve a place (with no obligation) please contact us using the details below:
PO Box 3255,
Littlehampton,
BN17 9AD
Tel: 01903 730 622
e-mail: debra.stanfield@seerpharma.co.uk
