PTI - international

Training Overview

Improve Your Ability to:

• Clarify the similarities and differences among GMP requirements for the U.S., EU and Japan and create a globally compliant manufacturing process
• Comply with the guidelines of all regulatory bodies by understanding the process of harmonization and the implementation of ICH Q7 and Q7A guidance documents in each region
• Meet international requirements for production of commercial as well as clinical trial supplies and become fully prepared for inspections
• Communicate more effectively by examining mutual recognition procedures and the types of information-sharing allowing among international regulatory agencies
• Comply with Quality System Regulations and establish a thorough quality program that ensures quality and manufacturing efficiency
• Plan for a global future by ensuring manufacturing operations located in the U.S. are compliant with international requirements
• Adjust to recent changes in the Japanese drug approval system to increase approval chances in the region

PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-05-123-L04, Initial release: 04/2005.