ASLC Devotions: More Insights on Remote Audit, Drug Registration, Continuous Manufacturing and more!

Gain More Insights @ Conference Webcasts

More contents are presented by CPhI China Virtual Expo Connect next week!
Register now for free to learn and network with industry experts on pharmaceutical remote audits, Indian API registration in China, and continuous manufacturing of drug products.

22 June
16:00 ~17:00
(UTC +8 China Time)

Best Practices in Pharmaceutical Remote Audits During COVID-19 and Beyond

Jim Fries
CEO, RX360

Introduction: This presentation will discuss the role that remote auditing has played in pharmaceutical quality during the coronavirus pandemic. It will discuss best practices, and observations from both the supplier and manufacturer point of view. The presentation will also cover the expected role that remote auditing will continue to play post COVID-19.
• Welome and Introduction
• What is a Remote Audit?
• Why Conduct a Remote Audit?
• Best Practices
• What is Next in the Remote Audit Arena?

23 June
16:00 ~ 17:00
(UTC+8 China Time)

Chengpei, Liu
Registration Manager
China Chimopharma

How Indian API Register in China

"Drug Registration Management Approach" was newly revised after 13 years on 30 March 2020 to encourage innovation and optimize and improve the efficiency of the drug review. It introduced the new concept and system, updated the registration management, established a link between the review and approval system, and strengthened the concept of whole life cycle of drug management.
Our company has been the exclusive agency of more than 80 international API suppliers and collaborated with over 700 domestic production enterprises. Referring to our business model and registration experience, the speech will focus on an overview of the registration and administration of imported APIs, related judicial institutions and laws and regulations, and declaration requirements and review process so as to together explore coping strategies and future industry trends.

24 June
16:00 ~ 17:00
(UTC+8 China Time)

Continuous Manufacturing of Drug Products Opportunities and Challenges

Dr. Deepak Hegde

Senior Vice President-CMC
EOC Pharma

Introduction: One of the innovations in the field of pharmaceutical manufacturing has been continuous manufacturing. The talk will outline the concept, features, potential benefits and control strategies used for continuous manufacturing. Quality/ GMP considerations for implementing continuous manufacturing in the small molecules space along with a key factor- how to bridge existing batch manufacturing with continuous manufacturing, would be addressed. Regulatory and Quality Considerations including a summary of current regulatory environment, relevant regulations and guidelines including industry stand on current guidances would be discussed. Quality/GMP Considerations and Post-approval implementation would also be explored in the talk.