Pre-Conference Session “From theory to practice: implementing API Process Knowledge

Highlights

Practical assistance and experiences how to implement API Process Knowledge from a quality and regulatory perspective of:

• Control Strategy
• Change Control
• Reprocessing and Rework

Objectives

This Pre-Conference Session provides an overview of the regulatory and quality GMP requirements and approaches for implementing API Process Knowledge in the pharmaceutical industry. During interactive sessions you will get to know:

• Which GMP and regulatory aspects have to be considered for establishing an adequate Change Control Management?
• What do the guidelines tell us for reprocessing and reworking? And what are the practical consequences during the production of APIs?
• What has to be taken into account when implementing control strategies?

Furthermore, you will have the opportunity to reach clarification on ambiguous issues by bringing your questions up for discussion.

This Pre-Conference Session ideally complements the following 27th APIC/CEFIC Global GMP & Regulatory API Conference.