Workshop Programme

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

Programme Outline

08:00 Registration and Refreshments
     
09:00 Workshop 1: Current Good Manufacturing Practices (cGMP) Regulatory Compliance 
  Workshop Leader:
Jayakrishnan P.
Senior Regulatory Specialist- US, EU and GCC countries
Al Jazeera Pharmaceuticals, KSA
     
 10:30 Coffee and Networking Break  
     
 11:00 Workshop 2: Handling of Quality Audits
  Workshop Leader:
Sherin Joseph
Quality Manager
Riyadh Pharma, KSA
     
  Key Topics in Focus:
• Audit Preparation
• Handling of Auditors
• Dos and Don'ts in Audits
• Opening Meeting Presentation
• Building Confidence to Auditors
• Response During Audit
• Document Review
• Response and Closure of Audit Observations
     
12:30 Lunch and End of Workshops