Dates - 25th - 26th May 2010
Price - £1160 + VAT
Audience
- QA professionals who are moving into biopharmaceuticals
- Senior managers and newly-appointed managers in biopharmaceutical companies
- R&D managers who need to understand the quality issues associated with the manufacture of biopharmaceuticals
- Pharmaceutical production managers
- Project managers who are moving into biopharmaceuticals
- Regulatory professionals with no previous experience of biopharmaceuticals
Course Content
- Types of biopharmaceuticals
- What is GMP?
- QA versus QC
- Quality systems approach to CGMP regulations
- Structuring R&D to facilitate product approval
- Designing the overall manufacturing process
- Production systems
- Purification
- Formulation
- Aseptic filling
- Pharmacokinetics and safety evaluation
- Process changes and improvements
- Issues with generic biologicals
To book a training course, please download the booking form
, complete and email to bookings@rssl.com