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Webinar On Transfer of Analytical

Methods and Procedures according to
USP 1224
Presented By Dr. Ludwig Huber
Scheduled On :Wednesday, April 22, 2015
at 13:00 Hrs

Hosting By
Compliance
Trainings

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Transfer of Analytical Methods and Procedures according to USP

1224
Product
Product Id
Id
Category
Category
Scheduled
Scheduled On
On
Duration
Duration

FDB1453
FDB1453
Food,
Food, Drugs
Drugs &
& Biologics
Biologics
Wednesday,
Wednesday, April
April 22,
22, 2015
2015 at
at 13:00
13:00 Hrs
Hrs
75
75 Minutes
Minutes

Speaker
Speaker

Dr.
Dr. Ludwig
Ludwig Huber
Huber

Login at
https://compliancetrainings.com/siteengine/Login.aspx
Webinar 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has included requirements for method transfer in its new draft
guidance from 2014 on validation of analytical methods.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

Speaker Profile

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of

(www.labcompliance.com), the global online resource for validation
and compliance. He is the author of the books "Validation and
Qualification in Analytical Laboratories" and "Validation of
Computerized Analytical and Networked Systems". He has given
multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR
Part 111 and Validation around the world. This included seminars,
workshops and presentations for the US FDA, China SFDA, Korea
MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other
national health care agencies. For more information, please visit
Dr.Huber's website (www.ludwig-huber.com).

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