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

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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
1300 Hrs
Hosting By Compliance Trainings
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Transfer of Analytical Methods and Procedures
according to USP 1224
Product Id
FDB1453
Category
Food, Drugs Biologics
Scheduled On
Wednesday, April 22, 2015 at 1300 Hrs
Duration
75 Minutes
Speaker
Dr. Ludwig Huber
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teengine/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 lt1224gt. 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new draft guidance from 2014 on validation of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 lt1224gt 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 

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• 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

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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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