Packaging and Labeling for Commercial and Clinical Products

  • Speaker:Peggy J. Berry
  • Date: 31st January 2018 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90216

$169

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Level of TrainingIntermediate

Why You should Attend:

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 this 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 will benefit:

  • Manufacturing personnel
  • Quality and compliance personnel
  • Regulatory personnel
  • Clinical operations 

Instructor:

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, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA.  In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society.  She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).

Available Options

Live Meeting Access: Attend the meeting Live via Webex

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Recording: Access it for 6 months from any location

$249

CD: Shipped within 2 working days

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Live + Recording: Attend Live + Access the recording for 6 months

$279

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$669

10 Member group: Access the Live Meeting online from any location globally

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Live + CD: Attend Live + Get a copy of the CD of the webinar

$389
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