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

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 produce 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.

This webinar will demonstrate how to ensure this compliance while enumerating cGMP requirements as they apply to the product or facility. The session will also review 21 CFR 4.4(b) and discuss best practices for the primary mode of action.

Learning Objectives:

• 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

Areas Covered in the Webinar:

• 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 Will Benefit:

Manufacturers of drugs and medical devices; organizations that make surgical or first-aid kits; manufacturers of biological product and devices - specific roles include:

• 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

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, Ms. Dunston 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, she has worked with US FDA agents to ensure compliance for her clients.

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

Follow us :