Analytical methods are a major tool in the pharmaceutical development to control the quality and integrity of the active drug substance or drug product. Methods are normally developed at one site and then transferred to one or more sites during the drug development process or as a post-approval activity. Qualifying analysts to perform these methods is a critical activity that would significantly impact the launch of a product. Activities of a method transfer process must be managed effectively to deliver an analytical method from one site to another or one department to another.

This live, interactive webinar will present fundamental principles of a method transfer and discuss options to conduct method transfer. A review of USP <1224> will also be included and key factors that would influence the transfer of analytical methods from one site to another will also be discussed.

Learning Benefits:

• Understand key factors of method transfer.
• Define roles and responsibilities of transfer team.
• Discuss requirements to qualify a laboratory.
• Develop appropriate transfer strategy to streamline processes.
• Understand transfer options listed in USP <1224>.
• Discuss different phases of method transfer.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Understand key factors of method transfer,
Define roles and responsibilities of transfer team,
Discuss requirements to qualify a laboratory,

11:30 AM 10 Minute Break

                Establish training activity,
Develop appropriate transfer strategy to streamline processes,
Understand transfer options listed in USP <1224>,
Discuss different phases of method transfer,

12:30 PMLive Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

• A copy of the presentation slides
• A certificate of training for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

• Quality Assurance Personnel
• Quality Control Personnel
• Research and Development
• Regulatory Affairs Professionals
• Auditors
• Validation

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.