Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated 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.
This 2-day workshop will explain the background to the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommended approaches. Interactive exercises will be included in the workshop.
- 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
Who will Benefit:
- QA managers and personnel
- Quality control scientists
- Method development scientists
- Analytical chemists
- Validation specialists
- Laboratory managers and supervisors
- Regulatory affairs professionals
- Training departments
- Documentation departments
Early bird seats are limited and based on first-come, first-serve.
The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.
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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ firstname.lastname@example.org
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
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After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
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