Two Day Validation, Verification and Transfer of Analytical Methods Workshop: Understanding and implementing guidelines from FDA/EMA, USP and ICH (Boston, MA, United States - September 12-13, 2017) - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH): 2-Day Workshop by Dr. Huber" conference to their offering.

This 2-day workshop will give attendees the background to understand the requirements, and even more significantly, it will focus on strategies and provide tools to implement most critical requirements. It will also provide 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 real life examples. After the course a variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what attendees have learned in the course.

Learning Objectives:

- Learn about the regulatory background and requirements for validation of analytical methods and procedures

- Learn how to plan, execute and document development and validation of methods developed in-house

- Be able to explain the different requirements for validation, verification and transfer of analytical procedures

- Understand the principles of validating methods developed in-house, verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial methods

- Be able to explain your company's strategy for method validation, verification, transfer and equivalency testing

- Be able to select test parameters, test conditions and acceptance criteria for different analytical tasks

- Be able to justify and document decisions about revalidation after method changes

- Be able to define and demonstrate FDA and EU compliance to auditors and inspectors

- Be able to develop inspection ready documentation during on-going routine operation

- Understand statistical evaluation of validation test results

- 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

- Consultants

For more information about this conference visit http://www.researchandmarkets.com/research/2rp8mk/validation

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Healthcare Services, Pharmaceutical Manufacturing

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Healthcare Services, Pharmaceutical Manufacturing