The FDA Group's Nick Capman sits down with Derek Wessman, a consultant based in Japan, to discuss the intricacies of conducting supplier audits in the Japanese life sciences industry. They explore the unique challenges and opportunities presented by Japanese suppliers and the cultural and regulatory nuances that impact auditing processes.

Discussion points include:

Language and Cultural Barriers: Derek explains how the significant language barrier and cultural differences can impact audit efficiency and effectiveness, often doubling the time required for audits.

Strengths of Japanese Suppliers: The conversation highlights the strengths of Japanese suppliers, including their focus on quality, well-organized facilities, and widespread ISO certifications.

FDA Inspections in Japan: Derek provides insights into the frequency and nature of FDA inspections in Japan, emphasizing the time constraints and logistical challenges faced by inspectors.

Data Integrity Challenges: The discussion covers common data integrity issues in Japanese companies, including shared logins and the use of unvalidated Excel files for critical calculations.

Cultural Impact on Quality Systems: Derek shares how Japanese business culture, including long-term employment and collective mindset, can influence quality management systems and CAPA processes.

Strategies for Effective Audits: The conversation provides practical advice for companies looking to audit Japanese suppliers, emphasizing the importance of local resources and cultural understanding.

Derek has been based in Japan since 2004 and has run his own consultancy since 2009. He specializes in helping Japanese companies navigate regulatory hurdles, FDA inspections, and compliance issues in the pharmaceutical, medical device, and combination product sectors. Derek's expertise bridges the gap between Japanese suppliers and global life science companies, offering unique insights into conducting effective audits in Japan.

____

The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

For project or resource needs, visit ⁠⁠⁠thefdagroup.com⁠⁠⁠.