DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Lifecycle Management of Analytical Methods and Procedures - Integrate design, development, validation, and ongoing performance verification according to new FDA and USP guidelines" conference to their offering.
The 2-day workshop will give attendees the background to understand the new Analytical Procedure Lifecycle requirements and even more importantly it will focus on strategies and provide tools to implement most critical requirements. It also provides templates and examples to develop inspection ready documentation. Interactive workshop exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions with life examples.. After the course a variety of tools such as SOPs, validation examples and checklists will be readily available at no additional cost on a dedicated website that can be used by attendees to easily implement what they have learned in the course.
Results of analytical methods and procedures are used as the key basis to make important decision during development and manufacturing of pharmaceutical products. Therefore all regulatory agencies expect the regulated industry to have procedures and measurements in place to ensure highest reliability, accuracy and precision of such methods and procedures. The procedures should cover all lifecycle phases from design, development, validation to on-going routine use.
Managing analytical methods and procedures according to the lifecycle approach got highest attention from regulatory agencies and industry task forces. For example, the new FDA guidance Analytical Procedures and Methods Validation for Drugs and Biologics starts with suggestions for method development and includes a chapter on Lifecycle Management of Analytical Procedures. USP's Validation and Verification Expert panel just proposed a new general chapter 1220: The Analytical Procedure Lifecycle.
- Learn about the regulatory background and requirements for managing the lifecycle of analytical methods and procedures
- Understand current and future industry trends: revised USP chapters 1225 and proposed chapter 1220: "The Analytical Procedure Lifecycle", 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 explain your company's strategy for analytical procedure lifecycle
- Understand risk management strategies throughout the procedure lifecycle
- Be able to design and execute a procedure specific control strategy based on risk
- 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
- Understanding what questions will be asked during audits and inspections and how to answer them
Who Should Attend:
- QA managers and personnel
- Quality control
- Method development
- Analytical chemists
- Validation specialists
- Laboratory managers and supervisors
- Regulatory affairs
- Training departments
- Documentation departments
The concept: 50 % of the time will be dedicated workshop type exercises using prepared fill-in templates and to interactive discussions.
Day 01 (8:30 AM - 4:30 PM)
08.30 AM - 09.00 AM: Registration
Introductions and Agenda Review
Lectures and Workshop Exercises
Lecture 1: Regulatory background and requirements
Lecture 2: Going through the new FDA Method Validation guidance - with focus on procedure lifecycle recommendations
Lecture 3: Preparing your lab for compliant validation studies
Lecture 4: The lifecycle overview on integrated design development, validation, and on ongoing performance verification
Day 02 (8:30 AM - 4:30 PM)
Lectures and Workshop Exercises
Lecture 5: The analytical target profile
Lecture 6: Procedure design and development
Lecture 7: Procedure Performance Qualification (Validation)
Lecture 8: Ongoing Performance Verification
For more information about this conference visit http://www.researchandmarkets.com/research/thpgch/lifecycle