FDA Established Conditions Reportable CMC Changes for Approved Drugs and Biologics

Duration: 90 Minutes
On June 1, 2015, FDA announced the availability of a draft guidance for industry entitled "Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products." The draft guidance is intended to address a "lack of clarity" about when chemistry, manufacturing, and controls (CMC) changes must be reported to FDA.
Controls Changes (CMC)
Instructor: Angela K. Dunston
Product ID: 501043

By way of background, FDA regulations require marketing applications for drugs and biologics to contain a CMC section that describes information such as the composition of the drug product, manufacture of the drug substance, and manufacture of the drug product. Regulations also require all changes after approval of an application to be managed and executed in conformance with current Good Manufacturing Practices (cGMP).

Why Should you Attend
The guidance has been developed to address the lack of clarity with respect to what chemistry, manufacturing, and controls (CMC) information in a marketing application constitutes an established condition or a "regulatory commitment" that, if changed following approval, required reporting to the FDA. For those changes that require reporting, a better understanding of a more effective post-approval submission strategy by the regulated by the industry.

Objectives of the Presentation
  • Regulatory expectations for CMC section
  • Established conditions defined and explained
  • Explanation of changed that can managed by the manufacturer
  • Explanation of changed that are reportable to the agency
  • Control Strategy techniques
  • Benefits to industry
Who can Benefit
  • Senior Management
  • Regulatory Affairs Management and Personnel
  • Compliance Officer and Personnel
  • Quality Assurance Management and Personnel
  • Process Engineering Management and Personnel
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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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