Date: 10-11 October
Location: Tokyo, Congress Square Nihon Bashi
An experience-based program for inspectors and API industry
PDA and ICH are offering a training course applying the requirements of ICH Q7 accepted world wide. The course is for practical implementation of GMP for APIs for industry and regulators – inspectors / reviewers
This course in Tokyo will provide insights on current observations provided by GMP inspectors from the EU, US FDA and Japan`s PMDA. Experts from industry involved in drafting these ICH guidelines will elaborate on the intentions of the working group and why the requirements had been established in ICH Q7.
All ICH Q7 Q&A sessions allow for open discussions enabling you to benefit from first-hand feedback in avoiding pitfalls in implementing the guideline and regulatory expectations. Inspectional observations will allow reviewers and CMC experts to learn about the efforts of industry to establish GMP. Inspectors will discuss various aspects of the ICH Q7 and expectations.
About the Course and Faculty
The faculty of this course will be GMP inspectors and API experts from industry and regulatory authorities, many of whom have participated as ICH expert working group members. The supporting documentation was developed by PIC/S and PDA.
The course is part of an ICH Pilot Program, the results of which will be used in developing a strategy on the future of ICH training and implementing a holistic training approach for industry and regulators.
For Further Information Please Contact
PDA Japan Chapter
4F 2-13-10, Torigoe, Taito-ku, Tokyo
PDA Members 75,000¥
Please fill in the registration form and send to PDA Japan Chapter by E-mail or Fax.