Overview: 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. 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. Areas Covered in the Session: Commercial packaging compliance Commercial labeling compliance Clinical packaging compliance Clinical labeling compliance Change control for materials, design and content) Pharmaceutical (drug/biologic) Who Will Benefit: Manufacturing personnel Quality and compliance personnel Regulatory personnel Clinical operations Speaker Profile: 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. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: [email protected]