San Francisco, California
London, United Kingdom
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.
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.
- 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
Handouts/ Bonus Material for Easy Implementation
(available as web downloads):
- 70-page primer: Validation of analytical methods (authored by Dr. Ludwig Huber)
- 10 SOPs related to method life cycle, validation, verification, transfer, quality by design, review and change of methods
- 5 Checklists, templates and examples for method lifecycle approach, validation, review, verification and for transfer of methods,
- Example acceptance criteria for different analytical tasks
- Example validation report
Who will Benefit:
- QA managers and personnel
- Quality control
- Method development
- Analytical chemists
- Validation specialists
- Laboratory managers and supervisors
- Regulatory affairs
- Training departments
- Documentation departments
Companies and departments
- Pharmaceutical development and Quality control laboratories
- Quality control laboratories of API manufacturers
- Contract laboratories
- Clinical Research Organisations
- Medical device companies
Note: Use coupon code NB5SQH8N and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.