A highly interactive course based on case studies and real life examples for injectable drug products. Through this training you will hear the current best proven industrial practices and learn how to master your next tech transfer of injectable products.
Scope provided by the training:
We will discuss quality by design as well as ICH Q9 and quality risk management principles. We will talk about how to strategize tech transfer for success as well as get the most out of partnerships with third parties and stakeholders.
Focus will be on the specific requirements of aseptic processing (e.g. fill and finish, media fills and annex 1) also from a regulatory perspective.
So far, this course has been successfully delivered almost a dozen times, both in house (i.e. Pfizer and Idorsia) and on line. The 3-half day on line training is also available via Symmetric, a well accredited provider of pharma and biotech trainings.
Who should attend:
- Pharmaceutical technologists;
- CMO managers;
- Manufacturing project managers;
- Regulatory affairs managers;
- Quality assurance managers;
- Technology transfer specialists;
- Manufacturing managers;
