Packaging and Labeling for Commercial and Clinical Products

This Program will discuss practical development of packaging design and optimizing the design to fit the intended purpose. You will learn to translate a clinical protocol into optimal package design. A review of the compliance requirements between clinical, commercial packaging and labeling will be completed. Review a case study of changing commercial packaging for optimization.

The program will discuss the process to establish an effective artwork change management and approval system, including real-life examples of system successes and potential pitfalls.

Areas Covered in the Session :

  • Laws and regulations related to packaging and labeling
  • Guidelines implemented during clinical, commercial packaging and labeling
  • Implementing SOPs to ensure compliance
  • Implementing appropriate change control procedures
  • Selection of materials for packaging and labeling
  • Required submission content for the IND/NDA related to packaging and labeling materials and procedures
  • Clinical packaging compliance
  • Clinical labeling compliance
  • Commercial packaging compliance
  • Commercial labeling compliance
  • Change control for materials, design and content
Who Should Attend:

  • Research and Development Departments
  • Quality Departments
  • Manufacturing Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • Clinical Operations Departments
  • Packaging and Labeling Departments

FDB2632

Peggy J Berry

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).

She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

Refund Policy

membership
  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