Training Course Syllabus:

Cold Chain: GDP Guidelines, Audits and Regulations Webinar

Time: 10:00 AM PDT, 01:00 PM EDT

Duration: 60 Minutes

Instructor: Regina Fullin

Description:

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.

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.

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

Seminar Summary:

Get trained on the U.S. and European requirements for the new GDP, along with a discussion of the types of risks to anticipate in a pharmaceutical supply chain. (see full course description)

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