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Methods Development, Validation Procedures, and Regulatory Compliance Issues |
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| Course Code: METD |
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| Learn the fundamentals of quality assurance, quality control, and analytical methods validation and how to improve your FDA, WHO and OECD regulatory compliance directives for analytical data submissions. Key topics covered include: conformity assessment; analytical method optimization during development; case studies in the improvement of validation characteristics; data integrity and statistical evaluation of analytical data; and more. |
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Dates - TBA |
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Check-in opens at 7:30 a.m. on the first day of the course.
Course runs from 8:30 a.m. to 5:00 p.m. each day. |
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Event Location: |
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TBA |
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Early Registration: |
$1,295 |
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Advanced Registration: |
$1,395 |
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Standard Registration: |
$1,495 |
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The course fee includes a course binder and a continental breakfast each day.
Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax, mail or phone and mention this discount and may not be combined with any other offer. |
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- Highlights of the guidelines derived from international standards-ISO 9000 and ISO 17025, GLP, GMP, etc.
- Conformity assessment–what it is, how it is applied.
- Analytical method optimization during development.
- Case studies in the improvement of validation characteristics.
- Method development and optimization in HPLC and wet chemistry.
- ICH, AOAC, and USP guidelines for methods validation and other standards.
- Regulatory submission packages for IND, NDA, ANDA and other phases of development.
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| Shib Mookherjea is a globally acclaimed speaker and consultant and has extensive experience in R&D, quality assurance, and quality management. |
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