Regulatory Compliance

Issue

Our client was a European pharmaceutical manufacturer expecting a pre-approval inspection by FDA. They had identified regulatory compliance as an important area for which further training was required. They wanted to improve understanding and interaction between the regulatory personnel responsible for submitting CMC variations and amendments and the non-regulatory personnel at manufacturing facilities involved in regulatory compliance.

Course Description

This course is aimed to provide a means to improve regulatory compliance by addressing the requirements for post-approval changes in Europe and the US and by detailing approaches to effective change management. The course also highlights strategies to minimise the need for such changes by effective writing of regulatory submission documents.

 

Course Outline

Day 1

1. The Legal Framework and Regulatory Authorities
2. FDA Pre-approval Inspections
3. Managing your Dossier for Compliance - Variations and Amendments
4. Managing your Dossier for Compliance - Change Management
5. Writing Module 3 to Minimise Variations and Post Approval Changes
6. Workshop - Managing your Dossier for Compliance

Contact Us

T: +44 (0)1276 671 166
F: +44 (0)1276 670 960
info@rrgconsultancy.com

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Find Us

RRG, Innovation House
Albany Park, Camberley
Surrey. GU16 7PL

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