Post-Conference Workshop

Tuesday, 11 September 2018

CGMP regulatory compliance and regulatory audits
Why CGMP audit workshop?

GMP regulations worldwide requires that companies have in place an internal system which helps in complying with regulatory requirements during audit

Globalization of pharmaceutical industry has put an onus to the regulators for assuring quality of pharmaceutical products manufactured in different locations and geographies. The integrated supply chain model has further increased sourcing of raw materials from various companies thereby an increase in comprehensive GMP audits have become today’s critical occurrence

This workshop will help business decision makers to understand the requirements, preparation and management of regulatory and customer audits. The overview is designed for those pharma professionals who have recently been involved or expect to be involved in international or external GMP audits

Programme:

  • Understanding the Rules, Regulations and Guidance surrounding cGMP Audits
  • CGMP regulations and guidance documents to help drug companies comply with the law
  • Preparation process of a cGMP Audit – ‘’Audits made easy’’
  • Developing strategies to fulfil requirements of various global regulatory authorities and achieve regulatory compliance