PDA-PIC/S Training Course, 10-12 February 2015, Brasilia, Brazil

On 10-12 February 2015, PDA Europe (Parenteral Drug Association) and PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) will offer training which will focus on the ICH Q7 Guideline on Good Manufacturing Practice (GMP).

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 current Q7 Implementation Working Group who are asked to develop Q&As to facilitate implementation.

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...

10-12 February 2015 Brasilia, Brazil