Packaging and Labelling for Clinical Products - 2017

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]

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