This training program will discuss optimizing your packaging design for commercial and clinical products and translating a protocol into effective packaging design. Attendees will learn how to implement an effective artwork change management system. Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.
- Laws and regulations related to packaging and labeling
- Guidelines implemented during commercial and clinical 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
- Commercial packaging compliance
- Commercial labeling compliance
- Clinical packaging compliance
- Clinical labeling compliance
- Change control for materials, design and content
Why Should you Attend?
Program will discuss practical development of packaging design and optimizing the design to fit the intended purpose. You will learn to translate a protocol into optimal package design. A review of the compliance requirements between commercial and clinical packaging and labeling will be completed. Review a case study of changing commercial packaging for optimization.
The program will review how to establish an effective artwork change management and approval system, including real-life examples of system successes and potential pitfalls.
- Manufacturing process development
- Process controls
- Selection of starting materials
- Control strategy
- Process validation evaluation
- Submission of information
- Life cycle management
Peggy J. Berry,
President & CEO ,
Synergy Consulting LLC
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).