Cold Chain: GDP Guidelines, Audits and Regulations

Duration: 60 Minutes
This webinar will provide the attendee a brief overview of U.S. and European requirements for Good Distribution Practices (the new GDP), along with a discussion of the types of risks to anticipate in a pharmaceutical supply chain. The webinar will go on to describe how to go about identifying and mitigating the risks, identify appropriate techniques to use for mitigating supply chain risks, and finally, to describe some of the tools at one’s disposal to prepare for an audit of one’s supply-chain program.
Instructor: Regina Fullin
Product ID: 501116
Objectives of the Presentation
  • Understand the supply chain requirements in the U.S. and in Europe
  • Identify the types of supply chain risks that are of concern in these regulations
  • Learn about risk management techniques that can help identify and mitigate supply chain risks
  • Learn about technology and tools available to better understand how shipping routes affect product integrity
  • Learn the process for adequate preparation for a supply chain-oriented audit
  • Learn about an element that can be considered most important for audit success
Why Should you Attend
This webinar is designed to inform attendees of the important elements to incorporate when establishing a sound supplier program for pharmaceutical products, especially for biologic products that require strict temperature controls for stability.

Areas Covered
  • Cold Chain/Supply Chain
  • Regulations in the U.S. and Europe
  • Disaster planning
  • Risk assessment techniques
  • Tools for assessing supply chain integrity
  • Preparation for audit success
Who can Benefit
  • Pharmaceutical Quality and Supply Chain Managers
  • Medical Device Quality and Supply Chain Managers
  • Food Quality and Supply Chain Managers
  • Anyone working in Supply Chain Quality who wants to better understand the requirements
Topic Background
Cold Chain is a new term in use for regulated medical products everywhere. This webinar is designed to give the attendee a greater context for what the cold chain is, why it is important, and what implications the cold chain has on the greater mission of providing safe, effective product to patients.
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  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Regina Fullin is the Director of Compliance Consulting Services at Compliance Team, Inc. (CTI), where she assists clients in the medical device and pharmaceutical industries to help them achieve ever-increasing compliance to regulations in the Pharma, medical device, and related industries. She began her career more than 20 years ago in a Quality role at Abbott Laboratories, and has worked in Quality roles at other companies, including GE Healthcare. Her particular areas of expertise focus on validation, equipment qualification, complaint handling, technical writing and remediation projects for companies requiring compliance assistance. Within her role at CTI, Regina also uses her writing skills to publish relevant and meaningful articles to help medical manufacturers stay current with regulatory changes, industry trends and improve product quality.

Regina is active in the American Society for Quality (ASQ), an international non-profit organization devoted to serving the needs of quality professionals. Regina is active in the Northeastern Illinois Section (1212) as Past Chair. In addition to her Section involvement, Regina also serves on the ASQ Food, Drug and Cosmetic Division, where she participates in conference/event planning and annual audit. Regina is also a Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and a Certified Manager of Quality-Organizational Excellence (CMQ-OE) with ASQ.
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