PDA-PIC/S Training Course, in September 2015, India

PDA Europe (Parenteral Drug Association) and PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) are organising two training focusing on the ICH Q7 Guideline on Good Manufacturing Practice (GMP) in India. The first training course will take place in Hyderabad on 14-15 September 2015 and the second in Ahmedabad on 17-18 September 2015.

ICH Q7 is the international standard that many regulators use to define GMP requirements for APIs. Participants will have an opportunity to learn from regulatory and industry experts at the 2015 PDA-PIC/S ICH Q7 Training on how these requirements are being interpreted and enforced. While the training will be conducted by PDA and PIC/S, this event includes members of the original ICH Q7 Expert Working Group and the Q7 Implementation Working Group that developped Q&As to facilitate implementation of Q7.

Participants will have the unique opportunity to discuss:

• How to Implement ICH Q7 and be Prepared for Inspections
• How to Receive Answers from API Manufacturing Site Inspectors
• GMP Principles
• Personnel, Facilities, Equipment, Cleaning
• Materials Management & Distribution
• Biotech API
• Manufacturing Controls
• Process Validation
• Quality System Elements
• Third Party Relationships
• EU Falsified Medicines Directive and More

At a Glance...

14-15 & 17-18 September 2015 Hyderabad & Ahmedabad, India