Established Condition – The New FDA Guidance

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.

Areas Covered in the Session :
Definition of Established Conditions
Elements of a Control Strategy that May be Considered Established Conditions
Sections of CTD that Typically Contain Established Conditions
Establishing Conditions as Part of the Application Submission and Review
Changes to Established Conditions

Who Will Benefit:
A must attend webinar for professionals/organizations in Pharmaceutical, Biologics, Contract Laboratories, API Manufacturers and Medical Device industries. The teams that would benefit include:
Senior Management
Regulatory Affairs Teams
Compliance Officer
Quality Assurance Teams
Process Engineering Teams
Change Management Professionals
Validation Specialists

Angela K. Dunston

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.

  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT

  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance