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Complianceonline, Online Web Event
2010-05-12
In this Verification of Compendial Methods training you will learn method verification according to <1226>, requirements for verification of compendial methods. FDA 483s on the subject of method verification. Why Should You Attend: USP <1226> recommends that all Compendial Methods must be evaluated in the laboratory prior to use for Lot Release and Stability Testing. The FDA requires that "The suitability of all testing methods used shall be verified under actual conditions of use". Poor compliance to these requirements has lead to recent 483s, warning letters and more severe regulatory actions This webinar will provide an in-depth discussion of USP <1226>, 'Verification of Compendial Methods' requirements. FDA 483s on the subject of Method Verification will be discussed to understand current FDA expectations. The factors under actual conditions of use which impact method performance and make method verification necessary will be addressed. Areas Covered in the Seminar: - FDA 483s related to method verification.
- Requirements of USP <1226>, 'Verification of Compendial Methods'.
- What are the current FDA expectations related to method verification.
- FDA 483s related to method verification.
- Requirements of USP <1226>, 'Verification of Compendial Methods'.
- What are the factors which impact method performance under actual condition of use?
- How compliance to USP <1226> and investment risk.
Who Will Benefit: This course is intended to provide training on how to evaluate compendial methods in order to comply with USP <1226>- QC personnel
- QC Supervisors and Management
- QA personnel
- QA Management
- Documentation management specialists
- Regulatory affairs personnel
- R&D Lab personnel
- R&D Lab Supervisors
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Organized by:
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ComplianceOnline |
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Invited Speakers:
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Nanda Subbarao, received her PhD in Bio-organic Chemistry from the Indian Institute of Technology in Bombay, India. She is currently a Senior Consultant with the Biologics Consulting Group. She is an ASQ Certified Quality Auditor, with expertise in the CMC, Analytical and Stability areas for Biologics and conventional small molecule drugs. Her hands on experience in the industry at Organics/LaGrange, Pfizer, Sandoz and Sun Pharmaceuticals included setup and upgrade of GMPs in analytical laboratories, leading construction/validation projects for Stability Facilities, set up of cGMP compliant systems for Stability Programs, management of stability studies in contract facilities, management of QC laboratories and CMC preparation from the IND to the Commercial stage. Her experience covers small molecule pharmaceuticals, including controlled substances and Stem Cell Products.
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Deadline for Abstracts:
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Call contact
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Registration:
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Online Event EVENT INFORMATION Contact Admin, Phone: +1-650-620-3915, Fax number: +1-650-963-2556.
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E-mail:
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admin@complianceonline.com
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