2022 - Understanding Combination Products: Navigating the Rules and Regulations

OVERVIEW
This webinar will begin by first defining combination products in terms of the complexities that combination products present to the organization from a device and pharma/biologic standpoint. The webinar will then move on to the regulations governing how combination products are regulated. Various scenarios will be presented that will discuss how and which regulations apply depending on the facility and the device. A job aid will be provided as a webinar enhancement that will make the complex process of regulation application simple to understand.
The approval process for combination products will also be detailed as it differs from a purely medical device or purely pharma or biologic product.
The webinar will complete a review of 483s that illustrate the concepts presented making real the approaches for regulatory and GMP application.
WHY SHOULD YOU ATTEND?
This webinar is essential for those who are currently manufacturing combination products or anticipating submitting potential products for approval. This webinar will provide the knowledge necessary to determine the regulations that apply to common combination product types. GMPs for combination products will also be discussed in addition to a discussion of the particular challenges facing manufacturers today.
AREA COVERED
Combination product examples
The complexity surrounding combination products
Combination product regulations
Combination product approval process
Combination product cGMPs
Warning Letter case study review
LEARNING OBJECTIVES
Define the term “Combination Products”
Identify and explain the US Regulations that pertain to combination products
Explain the combination product approval process
Identify and explain the GMPs for combination products
WHO WILL BENEFIT?
Regulatory, quality, and clinical professionals involved with combination product development and oversight
Product stewards
Business development executives involved in combination product strategic partnerships
R&D and product testing professionals
Combination of product supply chain professionals
SPEAKER PROFILE
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer, and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago.
For more detail, please click on this below link:
https://bit.ly/3xALk1q
Email: info-AT-247compliance.us
Tel: +1-661-336-9555
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