Course offering number:1003-706
Course ID:
2392
Combination Products: How to Approach the Proposed Manufacturing and Distribution Requirements
In Conjunction with Medical Device Summit
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training course is intended for managers, supervisors, engineers, chemists, scientists, technicians and formulators working within the
Pharmaceutical, Medical Device and Biologics Industries and will be especially valuable to anyone involved in or intending to become involved in
Combination Products. It will also be valuable to documentation specialists, auditors and those in regulatory affairs. Personnel from the
following departments will find the course beneficial:
• Research and Development
• Quality Assurance and Control
• Manufacturing/Operations
• Facilities
• Finance
• IT
• Audit
• Training
• Technical Support
This training will also benefit suppliers of equipment and services to the above industries.
Description
The FDA has recently published Proposed New Regulations addressing Combination Products. (21 CFR, Part 4) and established an office of
combination products. This 90-minute accredited online training course will present a strategy for compliance with these new regulations and to
assure that the necessary systems and metrics are in place.
Module 1:
• What is a Combination Product?
• Examples of Combination Products
• Why are these new regulations necessary?
• What are the most recent FDA proposed regulations?
Module 2:
• How can I assure that my systems and
work aren't
repetitious, while at the same
time not having some
requirement of the
regulations overlooked?
• Who should have responsibility for
monitoring these
systems?
• Which parts of the regulations are likely to
be the most
challenging, and how should I
address these parts?
Module 3:
• Post marketing safety reporting for
Combination Products:
Harmonizing the
requirements for Drugs, Devices, Biologics
and Tissue Products
• Metrics for monitoring and auditing these
systems
• Strategies for tracking how Office of
Regulatory Affairs
(ORA) will inspect
Combination Product manufacturing
sites
Question and Answer Session