Safety and efficacy of a drug product are established with clinical studies throughout drug development. Therefore, analytical procedures are required to be fully validated for their intended use of the approved conditions. When changes are made to an approval process, there are concerns of maintaining product quality as well as cost of process improvement. Pharmaceutical companies are required to establish a change control process to evaluate potential changes and minimize the impact of registration. Establishment of new specifications as a result of method changes will also be discussed.

This live and interactive webinar will focus on potential changes of analytical procedures, and how to develop a change control system that minimize impact of registration. characterization of these changes will also be discussed to ensure the analytical procedures continue to perform within validated state. Documentation system will also be discussed to complete the record of these changes and able to monitor the product as long as it is available on the market.

Learning Benefits:

• Understanding cGMP requirements of method validation.
• Review Q2 A&B for method validation activities.
• Discuss changes that may be necessary for analytical procedures.
• Discuss the key elements of change control system.
• Establish a change control so that these method changes can be verified.
• Documentation system necessary to verify that procedure continues to be valid within its intended use.
• Establish new specifications resulted from method changes.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Understanding cGMP requirements for method validation,
Change control: key element of the quality system,
Review Q2 A&B for method validation activities,
Discuss the key elements of change control system,

11:30 AM 10 Minute Break

                Establish a change control so that these method changes can be verified,
Documentation system necessary to verify that procedure continues to be valid within its intended use,
Establish new specifications resulted from method changes,

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.