Organization Name / Organize By
Complianceonline
Organizing/Related Departments
Complianceonline
Organization Type
Organization/Company
SeminarCategory
Both (Technical & Non Technical)
SeminarLevel
All (State/Province/Region, National & International)
Related Industries
Business Development
Administration/Management
Location
Palo Alto, California, United States
Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the pharmaceutical industry to have procedures in place to ensure suitable levels of reliability, accuracy and precision of such methods. The procedures should cover lifecycle phases from design, development, validation to on-going routine use.
Managing analytical methods and procedures according to the lifecycle approach has been recommended in recent FDA guidance documents and stimuli articles published by the USP. For example, the recent FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” contains a section on Lifecycle Management of Analytical Procedures, and ICH has recently published guidelines on product lifecycle management.
This 2-day course will explain the background to the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommended approaches.
Learning Objectives:
- Learn about the regulatory background and recommendations for managing the lifecycle of analytical methods and procedures
- Understand current and future industry trends: the concept of lifecycle management of analytical methods, recent USP General Chapter 1210 (Statistical Tools for Procedure Validation), and Quality by Design (QbD) principles for method development and validation
- Learn how to plan, execute and document design, development and validation of methods developed in-house
- Understand the principles of lifecycle management for compendial procedures and for managing method transfer
- Be able to develop a strategy for analytical procedure lifecycle management
- Understand risk management strategies throughout the procedure lifecycle
- Understand the concept of measurement uncertainty
- Be able to justify and document decisions about type and extend of revalidation after method changes
- Be able to define and demonstrate FDA, EU, USP and ICH compliance to auditors and inspectors
- Be able to develop inspection-ready documentation during on-going routine operation
- Understand what questions will be asked during audits and inspections and how to answer them
Registration Fees
Not Mention
Registration Ways
Email
Phone
Website
Other
Address/Venue
2479 E. Bayshore Road
Suite 260
Palo Alto, CA 94303, USA