Post-Forum Workshop

Tuesday, 11 September 2018

cGMP Regulatory Compliance and Regulatory Audits

GMP regulations worldwide require that companies have an internal system in place which helps them in complying with regulatory requirements during an audit. Globalisation of pharmaceutical industry has put an onus on the regulators for assuring quality of pharmaceutical products manufactured in different locations and geographies. Additionally integrated supply chain models have further diversified the sourcing of raw materials from various jurisdictions. This calls for pharmaceutical manufacturers to place further emphasis on meeting the evolving quality standards and regulatory requirements.

The workshop focuses on helping business decision makers to understand the requirements, preparation and management of regulatory and customer audits. The workshop programme will be of interest to professionals in pharmaceutical manufacturing who have been involved in GMP audits.

Workshop Outline:

  • Understanding rules, regulations and guidelines surrounding cGMP audits
  • Developing strategies to fulfil regulatory requirements and achieve regulatory compliance
  • cGMP regulations and guidance documents to help drug companies comply with the law
  • Preparation process of a cGMP audit – “Audits made easy”

By attending the workshop you will be able to:

  • Gain a better understanding of the FDA regulatory requirements for pharma manufacturing
  • Decode GMP compliance from a regulator’s perspective
  • Discover ideas on how to embed the principles of GMP into your strategic approach to business
  • Learn what to look for in achieving regulatory compliance in your organisation
  • Understand how to prepare for an FDA inspection and/or a customer audit