2015 - Webinar On Transfer of Analytical Methods and Procedures according to USP 1224

Description :
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new draft guidance from 2014 on validation of analytical methods. This seminar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.
Areas Covered in the Session :
FDA and International expectations for method transfer
Examples of FDA warning letters and how to avoid them
The FDA Guidance on method transfer.
The USP chapter <1224>: history, status, future
Four approaches for analytical method transfer and testing
Responsibilities of the transferring and receiving laboratory
Developing a transfer plan and a pre-approval protocol
Conducting comparative studies
Criteria and approaches for risk based testing: what, when, how much?
The importance and selection of acceptance criteria
Dealing with technology transfer: validation requirements, regulatory notification.
Method transfer from standard HPLC to UHPLC
Most likely failures during method transfer
Handling deviations from documented acceptance criteria
Criteria for transfer waiver (omission of formal transfer)
Method transfer protocol and summary report
For easy implementation, attendees will receive:
SOP: Transfer of Analytical Methods
Checklist: Transfer of Analytical Methods and Procedures
Master Plan template and examples: - Transfer of Analytical Methods and procedures
Who Will Benefit:
Lab Supervisors and Managers
QA managers and personnel
Analysts
Research & Development in Pharmaceutical industry
Pharmaceutical quality control
Contract laboratories
CROs
Consultants
Teachers
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com
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