Pharmaceutical Analysis for Small Molecules and Regulatory Requirements: 2-Day In-Person Seminar
23rd & 24th of August 2018 at Hilton Singapore by Behnam Davani, Senior Consultant and Managing Director, Davani Pharmaceutical Consulting.
Short Course Description:
The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval to market their products. Therefore, other related supporting studies such as analytical instrument qualification, analytical life cycle management (development, validation, verification, method transfer), setting specifications, stability studies, and regulatory or compendial approval are examined.
Due to global nature of pharmaceutical industry, other quality topics on both regulatory (ICH) and compendial harmonization are also covered. These topics are valuable for scientists directly or indirectly involved with the drug development, analysis. stability studies or regulatory/compendial submissions. This course is based on a recent book entitled "Pharmaceutical Analysis for Small Molecules" by Dr. Davani which has been published by Wiley in 2017. In addition, examples and case studies will be provided based on insights and extensive experience in developing and implementing these topics in industry/pharmacopeia. Guidance and advice will also be provided based on interactions with global pharmaceutical industry, FDA and other regulatory authorities worldwide.
Drug Approval Process and Regulatory Requirements (private standards)
Pharmacopeias and Compendial Approval Process (public standards)
Compendial Harmonization Process
Chromatography System Suitability Requirements
Allowed Adjustments of Chromatographic System Parameters
Common Methods in Pharmaceutical Analysis (typically compendial)
Common Calculations for Assays and Impurities and Other Specific Tests
Analytical Instrument Qualifications including DQ, IQ, OQ, PQ
Analytical Method Validation
Analytical Method Verification
Analytical Method Transfer
Specifications including how to Handle Out-of-Specification (OOS) and Out of Trend (OOT)
Impurities including Organic, Inorganic, Residual Solvents and Elemental Impurities
Alternative to Official procedure and options
Who will Benefit:
Pharmaceutical Industry, Contract Laboratories (CRO), government (FDA or regulatory authorities), Academia.
Lab Supervisors and Managers
QC Managers and Personnel
QA Managers and Personnel
Pharmaceutical scientist/Pharmacists working in Industry
Senior or Graduate students (chemistry, pharmaceutical, Ph*rm*cy)
Below is the seminar link to view more details and download brochure:
Registration Price is only $1,299, with significant discounts available for more than 1 attendee. Use Coupon Code: 326062 to avail flat 10% off.
Budget constraint? We have special corporate discounts available up to 30%, for more information please write to TW9oYW1tYWQgISBJcnNoYWQgfCBDb21wbGlhbmNlT25saW5lICEgQ29t
or call +1 650-332-0381.