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Pharmaceutical Analysis for Small Molecules and Regulatory Requirements

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Hilton Singapore

581 Orchard Rd

Singapore, 238883

Singapore

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Refunds up to 30 days before event

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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.

Learning Objectives:

  • 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
  • Stability Studies
  • Degradation Studies

Who will Benefit:

Pharmaceutical Industry, Contract Laboratories (CRO), government (FDA or regulatory authorities), Academia.

  • Analytical/Chemists
  • Lab Supervisors and Managers
  • QC Managers and Personnel
  • QA Managers and Personnel
  • Regulatory Personnel
  • Compendial Liaisons
  • Pharmaceutical scientist/Pharmacists working in Industry
  • Senior or Graduate students (chemistry, pharmaceutical, pharmacy)

Below is the seminar link to view more details and download brochure:

https://www.complianceonline.com/small-molecules-pharma-analysis-seminar-80578SEM

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 Mohammad.Irshad@ComplianceOnline.Com or call +1 650-332-0381.

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Date and Time

Location

Hilton Singapore

581 Orchard Rd

Singapore, 238883

Singapore

View Map

Refund Policy

Refunds up to 30 days before event

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