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Pharmaceutical Analysis for Small Molecules and Regulatory Requirements (CO...

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Pharmaceutical Analysis for Small Molecules and Regulatory Requirements


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Pharmaceutical analysis is an important and integral part for the determination of quality including identity, purity and strength of the drugs. In addition, related studies and programs are needed to assure the performance of the drug products. It requires analysts to acquire a solid understanding of analytical chemistry and a thorough appreciation of pharmaceutical requirements to address these challenges. Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. This course is designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background. The topics provide comprehensive introduction to the drug development, analysis and related studies for small molecule drugs (non-biologics).

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.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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)


AGENDA

Day 01(8:30 AM - 4:30 PM)

8:30 AM - 8:59 AM: Registration and Meet & Greet.
9:00 AM - 10:00 AM: Lecture 1
Seminar objectives review, expectations and scope.
Drug Approval Process and Regulatory (FDA) Requirements (private standards)
Pharmacopeias and Compendial (USP) Approval Process (public standards)
10:00 AM - 11:00 AM: Lecture 2
Compendial Harmonization Process
Chromatography System Suitability Requirements
Allowed Adjustments of Chromatographic System Parameters
11:00 AM - 12:00 Noon: Lecture 3
Common Methods in Pharmaceutical Analysis (typically compendial)
Common Calculations for Assays and Impurities and Other Specific Tests
12:00 Noon - 1:00 PM: Lunch
1:00 PM - 2:00 PM: Lecture 4
Analytical Instrument Qualifications
Instrument Categories
Qualification Phases (DQ, IQ, OQ, PQ)
2:00 PM - 3:00 PM: Lecture 5
Analytical Method Validation (typical validation parameters)
Specificity
Precision/Accuracy
Linearity/Range
LOD and LOQ
3:00 PM - 4:00 PM: Lecture 6
Analytical Method Verification
FDA and USP Requirements
Factors to Consider
4:00 PM - 4:30 PM: Lecture 7
Analytical Method Transfer
Different Approaches


Day 02(8:30 AM - 4:30 PM)

8:30 AM - 8:59 AM: Registration and Meet & Greet.
9:00 AM - 10:00 AM: Lecture 8
Seminar objectives review, expectations and scope.
Setting Specifications FDA regulations and ICH guidelines (Q6A)
Out-of-Specification (OOS)
Out of Trend (OOT)
How to handle OOS and OOT?
10:00 AM - 11:00 AM: Lecture 9
Organic Impurities
USP General Chapters , ,
ICH Guidelines (Q3A and Q3B)
Classification
Qualification
11:00 AM - 12:00 Noon: Lecture 10
Residual Solvent
ICH Q3C and USP
Classification
Limits and Analysis
12:00 Noon - 1:00 Lunch
1:00 PM - 2:00 PM: Lecture 11
Elemental Impurities
ICH Q3D and USP and
Other Types of Impurities
Alternative to Official Procedure and Options
2:00 PM - 3:00 PM: Lecture 12
Stability Studies (Q1A and other ICH Guidelines)
Regulatory Requirements
Stability Protocols
Accelerated Studies
Long-Term Studies
Intermediate Studies
3:00 PM - 4:00 PM: Lecture 13
Stability Studies (Continued)
Bracketing and Matrixing
Degradation (Stress) Studies
4:00 PM - 4:30 PM: Summary and Review




SPEAKER


Behnam Davani


Behnam Davani
Senior Consultant and Managing Director, Davani Pharmaceutical Consulting


Dr. Behnam Davani is an Independent Senior Consultant and Managing Director of Davani Pharmaceutical Consulting. He has a Ph.D. degree in analytical chemistry and holds an MBA degree. Dr. Davani has more than 28 years of experience in industry, compendial/regulatory science and training. He has extensive experience as faculty for the development and teaching of several compendial and cGMP courses both domestically and internationally for USP Global Education Program. Dr. Davani is also editor and author of a recent book: "Pharmaceutical Analysis for Small Molecules", published by Wiley in 2017.

Prior to forming his own consulting company in 2017, he worked at USP for 17 years in different capacities including Director of Chemical Medicine Department and the Principal Scientific Liaison. His last responsibly at USP was the scientific management of the content development and teaching of USP Education courses for stakeholders worldwide. He was also a faculty for several Pharmacopeial Education courses both domestic and internationally. These topics include validation/verification/transfer of analytical procedures, impurities in drug substances and drug products, compendial HPLC, residual solvents, spectroscopy and stability studies for pharmaceutical products. In addition, he provided scientific support to the USP International Regulatory Affairs Department and Global Public Health Department for outreach and training for international regulatory agencies. Before joining USP in 1999, Dr. Davani worked in industry in various technical management positions for more than ten years.


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