Combination Products-The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products

Duration: 120 Minutes
The FDA has ensured that clear FDA requirements were in place for drugs, devices, biological produces as well as Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). However, there were no regulations in place to clarify and explain the application of cGMP requirements for combination products. The FDA is seeking to change that with the issuance of a guidance document that describes and explains the final rule on cGMP requirements for combination products. This webinar is in place to describe and explain the FDA current thinking by reviewing the guidance document in detail.
FDA Requirement
Instructor: Angela K. Dunston
Product ID: 501219
Objectives of the Presentation
  • Key definitions
  • Overview of Final Rule
  • The role of the Lead Center and other Agency Components
  • How to demonstrate compliance
  • cGMP requirements as they apply to product or facility
  • Control of changes
  • Review of 21 CFR 4.4(b)
  • Primary Mode of Action
Why Should you Attend
One of the goals of the agency is to protect the public from unsafe products.Firms that understand how cGMP requirement apply to their firm will reliably protect a product that imbues confidence with the Agency as well as the public. Building and maintaining a high compliance level would allow the Agency and the firm to move products through the regulatory system most efficiently.

Areas Covered
  • Introduction
  • Background
  • General Considerations for cGMP Compliance
  • Review of cGMP requirements in 21 CFR 4.4(b)
  • Applications of cGMP requirements for specific types of combination products
  • Primary mode of action and its importance
Who can Benefit
  • Senior Management
  • Regulatory Affairs management and personnel
  • Compliance Officer and personnel
  • Quality Assurance management and personnel
  • Research and Development
  • Validation
  • Auditing Management and professional
  • Quality Control management and professional
  • Legal
  • Contract Manufacturing and Contract Testing Facilities
Topic Background
FDA has provided clear guidelines explaining the cGMP requirements for Combination Products. The streamlines approach under 21 CFR 4.4(b) provides that combination product manufacturers may meet the requirements of both the drug cGMPs and device QS regulation by designing and implementing a cGMP operating system that is demonstrated to comply with the regulation that is more application for the intended use of the product.
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Instructor Profile:
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.

During these 20 years, Angela has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure compliance for her clients.

The international experience obtained has assisted global organizations such as Johnson and Johnson, the Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.
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