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, Ph*rm*cy, 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:LunchAM-PM Tea/CoffeeSeminar MaterialAttendance 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 worldwideLearning 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, Ph*rm*cy)
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
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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