Packaging and Labeling for Commercial and Clinical Products
|Speaker||:||Peggy J. Berry|
|Date||:||24th May 2019|
|Time||:||10:00 AM PST | 01:00 PM EST|
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.
Why Should You Attend:
This program will discuss the practical development of packaging design and optimizing the design to fit the intended purpose. Participants will learn how to translate a protocol into an optimal package design. A review of the compliance requirements between commercial and clinical packaging and labeling will be completed. The course will review a case study of changing commercial packaging for optimization.
The program will also review how 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:
- Commercial packaging and labeling compliance (required text; prohibited text; format and layout requirements for various types of packaging and labeling; filing and approval requirements)
- Design change control (change control review and approval process; requirements for agency approval; SOP for the process; reviewing, tracking and reporting design changes)
- Clinical packaging and labeling development and compliance (required text; format and layout requirements; considerations for blinding and global clinical trial requirements)
Who will Benefit:
- Manufacturing Personnel
- Quality and Compliance Personnel
- Regulatory Personnel
- Clinical Operations
- Packaging Technology
- Labeling Coordination
- Package Engineers
- Packaging Operations
- Regulatory Affairs
- Sales and Marketing
- Quality Assurance Consultants
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).