#Japan #pharmaceutical #Webinar #Chiyoda #Impurities

Join Our Webinar on Pharmaceutical Impurity Management

The pharmaceutical industry is under increasing scrutiny regarding the quality of its products, especially generics, due to several recent quality control issues. To address these concerns, CMC Research Co., Ltd. is hosting a seminar titled "Key Points on Impurity Management in Pharmaceutical Manufacturing and Regulatory Responses" on June 17, 2025, from 10:30 AM to 4:30 PM, via Zoom.

About the Seminar

This comprehensive webinar will feature expert speaker Hikaru Hashimoto, the CEO of Pharmaceutical Research and Development Consulting, who brings a wealth of experience in the field. Participants will gain deep insights into critical regulations and industry trends, such as GMP (Good Manufacturing Practice), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), and how to handle impurities effectively while ensuring compliance with regulatory authorities.

Key Topics Covered:

• - Overview of GMP, ICH, and PIC/S regulations.
• - Handling impurities in pharmaceuticals, including genotoxic impurities and elemental impurities management.
• - Knowledge about residual solvents and change control with respect to setting quality standards.
• - Evaluating quality equivalence in generics and ongoing trends in the pharmaceutical industry.

Audience

This webinar is intended for all professionals working in the pharmaceutical sector, including researchers, quality assurance personnel, and manufacturing experts.

Pricing & Registration

• - General Admission: ¥55,000 (incl. tax)
• - CMC Research Newsletter Subscribers: ¥49,500 (incl. tax)
• - Academic Price: ¥26,400 (incl. tax)

The registration fee includes course materials and access to a recording of the seminar for later viewing. Don't miss this opportunity—questions can be raised during the Q&A session!

Why Attend?

Recent incidents, like the valsartan crisis involving nitrosamine contamination, highlight the importance of stringent impurity management. Mishandling impurities can lead to severe repercussions for companies. This seminar aims to emphasize the significance of understanding impurity management per the ICH Q11 and M7 guidelines, facilitating a robust production process that prevents quality issues.

Seminar Schedule:

1. Quality Assurance Systems in Pharmaceuticals
2. GMP Overview
3. Insights on ICH Guidelines
4. Updates on PIC/S Regulations
5. Establishing Production Methods and Setting Acceptable Ranges
6. Key Process Parameters
7. GMP Guidelines for Clinical Trial Drugs
8. Identifying Starting Materials
9. Genotoxic Impurities Management
10. Elemental Impurities
11. Change Management and Its Necessity
12. Trends in the Generic Pharmaceutical Market
13. Responding to Regulatory Authorities
14. Session Wrap-up

About the Speaker

Hikaru Hashimoto
CEO of Pharmaceutical Research and Development Consulting
With a Master's degree from Kyushu University and extensive experience in pharmaceutical manufacturing and development, he has contributed significantly to the understanding of impurity issues in drug production. His expertise will guide attendees in navigating the complexities of regulatory compliance effectively.

Don't Delay – Register Today!

Visit our official site to sign up and secure your spot for this engaging learning opportunity. Make sure to prepare questions for our speaker, as this session includes a Q&A segment!

For further details and registration, please check our website at CMC Research.

Take the step to ensure the quality and compliance of your pharmaceutical production!