SCOPE
Withover 30 years’ of experience, our subject matter expert will deliver an in-depth insight into the requirements of Regulatory and ICH guidelines, a necessity in the development of quality biopharma product. You will be provided with clarity on these guidelines and will look at how Enhanced or Quality by Design can become an extremely useful and an inherent part of your process development strategy.
This 2 day course will familiarise you with all the latest literature, encompassing EMA and FDA product development guidance and a comprehensive review of the ICH Quality Guidelines (Q1 – Q12). Not only will you gain a thorough understanding,you will also be provided with direction into correct usage that will benefit you in the workplace.
With case studies, group discussion and teamwork, you will be taken through the process for ‘mapping out needs’ and a phase related approach, for enhanced or QbD type process development. Once armed with a thorough knowledge of relevant,up-to-date guidance you will learn how to fully develop this into an ICH defined, process development workflow.
SUITABILITY
This in-depth course is suitable for biopharmaceutical professionals within the disciplines of Quality Assurance, Manufacturing, Regulatory, Process Design,Validation, Clinical Trials and Quality Control.
By the end of this course you will:
- Have an excellent understanding of both Regulatory Agency guidance and the ICH Quality guidance, linked to process development.
- Also have attained a practical approach to QbD and enhanced process development.
- Gain the necessary knowledge needed to generate a regulatory dossier.
