Course Description

One is hard-pressed to find anyone in the drugs/biologics/medical device industry who is not aware of SOPs (Standard Operating Procedures). Unfortunately, quality and usability vary widely. Many SOPs fall short of fulfilling their role as compliance and training tools. Many in the industry view SOPs as a necessary evil; but it does not have to be so.

The goal of this web seminar series is to help attendees create user-friendly SOPs that continuously support standards for quality and validity of data, as required by the regulations, while also providing value to their users.

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Learning Objectives

• Gain insight into a strategy for setting up the SOP globalization project
• Examine a methodology for developing effective global SOPs
• Discuss lessons learned by pharmaceutical organizations and common pitfalls to avoid

Who Should Attend

• SOP Authors/Reviewers
• Quality Assurance Auditors
• Clinical Monitors
• Site Managers
• Line Function Heads
• Project Managers

Instructor

The course will be led by one of the following instructors:

Irina Colligon

Click here for complete trainer biographies

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.