CMC systems and processes play a pivotal role in the development, licensure, manufacture, and ongoing marketing of biopharmaceutical and device products that are consistently effective, safe, and high quality for patients.
DIA's CMC Workshop will provide a thorough understanding of the regulatory, technical, and quality requirements and strategies needed to support problem-solving as well as continuous improvements and innovation in biopharmaceutical manufacturing. Opportunities for interactive sharing of information and approaches will be an important part of the program.
This program has been developed in collaboration with the DIA CMC Working Group and Regulatory Affairs Community.
Previous attendees have said:
"The event was a great combination of high-quality science, current and emerging trends in the global regulatory environment, and outstanding networking opportunities with senior pharma and agency leaders."
"It was a great event, very relevant topics but also a great opportunity to network."
Content Preview WebinarCompliance and Change Control: Checking that the Manufacture/CMC is Maintained in Accord with the Terms of the License
March 13 | 10:00-11:00AM ET
This webinar will take on the complex problem of managing global post-approval CMC changes.
Who should attend?
Professionals involved in:
- CMC Regulatory Affairs
- CMC Writing
- Quality Assurance/Quality Control
- Regulatory Compliance
- API Development and Manufacturing
- Formulation Development and Manufacturing
- Analytical Development
- CMC Lifecycle Management
- CMC Project Management
LeeAnn L Chambers, MS • Principal Research Scientist, Global Regulatory Affairs, CMC - Devices
Eli Lilly and Company, United States
Andrew Chang, PhD • Vice President, Quality and Regulatory Compliance, QI&I, Corporate Quality
Novo Nordisk A/S, United States
Cheryl Emery • Associate VP, GRACS and Global Head CMC Pre-Approval Pharmaceuticals
Merck Research Laboratories, United States
M. Scott Furness, PhD • Deputy Director, ONDP, OPQ, CDER
FDA, United States
Annie W Sturgess, PhD • Vice President, Global Regulatory Sciences, CMC
Bristol-Myers Squibb Company, United States