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Practical HPLC in Pharmaceutical Analysis |
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| Course Code: PRHP |
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Analytical procedures are used to assure that the drug product meets applicable standards of identity, strength, quality, and purity during its expiration dating. The majority of analytical methods used in pharmaceutical development are HPLC analyses. cGMPs require stability indicating methods to monitor the drug product’s stability profiles. Therefore, method development and validation significantly impact the drug development process. Additional expectations are also placed on the monitoring of impurities and degradation products.
This course focuses on reversed-phase analysis of drug substances and drug products (small molecule). It will discuss forced degradation strategies to develop stability-indicating analytical procedures. A review of ICH guidelines on validation and impurities will be done to help Pharmaceutical Manufacturers to gain better understanding of method validation by phases of drug development and regulatory expectations through a review of warning letters.
Registrants will need to purchase a copy of Modern HPLC for Practicing Scientists, by Dong (Wiley-Interscience, 2006) in addition to their registration, and which is available for purchase at a discount through ACS. Please contact Andrea Adams to purchase your copy. Quantities are limited. |
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Date - 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: |
$795 |
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Advanced Registration: |
$895 |
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Standard Registration: |
$995 |
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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 or mail and mention this discount. May not be combined with any other offer. |
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- Design your forced degradation studies to support method specificity
- Review cGMP regulations that govern the pharmaceutical laboratory
- Understand ICH regulations surrounding method validation and stability-indicating procedures (Q2A&B)
- Impact of developing stability indicating methods
- Understand Q3 for impurities monitoring
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| Kim Huynh-Ba is a Technical Director at Pharmalytik Consulting and Training Services. She teaches Advanced HPLC in Pharmaceutical Analysis; Analytical Method Transfer of Pharmaceutical Products; Stability Testing in Pharmaceutical Development; Practical HPLC in Pharmaceutical Analysis. She is the editor of “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (Springer 2008) and “Pharmaceutical Stability Testing to Support Global Markets” (Springer 2009). |
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