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.
Objectives of the Presentation
Why Should you Attend
- 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
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.
Who can Benefit
- 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
- 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
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.