Liquid Chromatography Boot Camp Plus For pharmaceutical and Biopharmaceutical industries

Transcription

1 2019 Liquid Chromatography Boot Camp Plus For pharmaceutical and Biopharmaceutical industries Features : Solid understanding of LC theory and practice Modern HPLC instrumentation How to develop a method? How to control resolution? Advanced Topics Method Development Analytical Quality by Design progamma Science Corporation Pointe- Claire 6700 TransCanada, Montreal Quebec, Canada. Also avaliable : Online Training Center (OTC) Version Space is Limited Act Today!

2 Course Objectives Stay Current Analytical technologies are changing and evolving very rapidly. Many companies are involved in improving and enhancing qualification techniques and exploring alternatives that are more efficient to reduce testing time. This boot Camp is designed to provide complete up-to-date techniques and up to advanced level including analytical quality by design. We have included an online option to respond to scientists who do not have time to attend a 5 days course. We have allowed 15 days for our online course will provide you with an update of practices and technologies that are shaping today s analytical method development and validation needs. Who will benefit? Pharmaceutical and Biopharmaceutical, who have some background in computer validation and need a step-by-step, in-depth understanding of ERP validation, especially within: Analytical Chemists AQbD project Managers AQbD team Analytical R&D Regulatory Affairs Analytical Development supervisors Compliance Auditing Validation This course is also of interest to Consultants and contract research organizations that specializes in computer system validation. Learning Objectives 1. Discover, review, and solidify your knowledge about LC theory and practice. 2. Learn modern systematic approach to HPLC method development 3.You will be exposed to the latest modern methods development software, and how to drastically CUT DOWN on methods development time without even running a HPLC? 4. Discover the latest advances in gradient elution. 5. You will receive the latest information on HPLC method validation and how to qualify HPLC equipment and finally how to treat validation data statistically. 6. Learn how to handle difficult separations in pharmaceutical and biotechnology. 7. Discover modern sample preparation techniques that are important to successful separation. 8. Understand the Basic Fundamentals and Approach of AQbD 9. Understand Risk-Based GMP Compliance and FDA, and ICH requirements 10. Review Strategies for Defining Risk, Risk Factors and Risk Prioritization 11. How to develop QTMP, how to use risk base tools to link to ATP 12. How to develop MODR, and define CPP

3 Distinguished Speakers Ady Sadek, M.Sc., P.Chem is president of progamma Science Corporation, Previously he spent 25 years in the pharmaceutical industry with BioResearch, Schering-Plough and Novartis Pharmaceuticals, holding positions such as Manager of Analytical & Development Labs, Director of Quality and Director of Quality Audit. He holds two master degrees in Organic and analytical chemistry. Ady s vast experience in process design and analytical method development and validation started in 1981, when developing new formulations for FDA submissions. He has been involved in many validations and his experience extends from analytical method development to validation and technology transfer. He provides strategic QbD and PAT projects management throughout Canada, USA and China.He also, has provided subject Matter Expert guidance for gap analysis and remediation of computer systems validation for major pharmaceutical biopharmaceutical and medical devices companies. He was actively involved in designing and developing computer interfacing systems to automate laboratory instruments such as GC, HPLC, UV and IR and plant automatio such as PLC, SCADA and DCS. He has combined his extensive experience in quality systems, validation as well as computer system to provide leading cutting edge consulting and training throughout Canada, USA, China and Europe to several multinationals. David Tozer, Ph.D., CQE, Six Sigma black belt is president of Qualitiqua, Dr. Tozer has more than 25 years of experience in Quality management, in the pharmaceutical and software industries, after earning a Ph. D. in physics at the University of Waterloo. He then worked in the quality field for many years in the pharmaceutical, defence, aerospace, medical, manufacturing, and software industries. In industry, Dr. Tozer successfully led teams of people to improve their organizations using the Six Sigma methodology. He is an ASQ CQE and teaches quality courses for the ASQ and a joint ASQ McGill university program. Dr. Tozer trained over 500 people in various topics in the quality field..

4 Day 1 8:00 Registration- Continental Breakfast 8:30 Course Starts INTRODUCTION Principles of Chromatography Branches of Chromatography Advantages of HPLC Terminology INSTRUMENTATION 9:00 am course starts 10:30 break/coffee 12:00 1:00pm lunch 2:30 break/coffee 4 :30 course ends Hardware Pumps Detectors Recorders, Integrators Chromatography data stations Instrument Maintenance & Troubleshooting CHROMATOGRAPHY COLUMNS Column materials Column Types Column selection guides Best column properties Column packing Column maintenance CHROMATOGRAPHIC DATA ACQUISITION AND PROCESSING Principals Different models Hardware and software Workshop I 4:30 End of day one

5 Day 2 8:30 Course Starts DEVELOPING AN LC SEPARATION Defining the Problem Standardization of Conditions Operating Parameters Preparation of Sample Steps to a Satisfactory Separation CONTROLLING RESOLUTION Dealing with Excessive Resolution: Solvent ming Flow ming Dealing with Insufficient Resolution-Recycling QUANTITATION With Internal Standard Without Internal Standard Workshop II 4:30 End of Day 2

6 Day 3 Advanced Topics NEW ADVANCES IN HPLC INSTRUMENTATION Solvent Delivery systems Detection systems Advanced troubleshooting NEW ADVANCES IN HPLC COLUMN PACKING DESIGN Porous Packing Non-porous and superficially porous packing Mondithic columns Sol-gel silica columns Practical operation of bonded-phase columns: Types of Bonded-Phase Chromatography Characteristics of Silica Gel Preparation of Bonded Phases Phase Chain Length and its effect Modes of Reverse-Phase Chromatography Ion-Pair Chromatography WHY SUBSITUTE COLUMNS? How to characterize columns? Column selectivity How columns can be similar? How to select columns for various analytical methods ( LC/MS)? CHIRAL LC SEPARATION What is chiral compounds? Column selection and conditions Method development hints OPTIMIZATION IN LIQUID CHROMATOGRAPHY Resolution and Efficiency Analysis Time, Flow Rate, and Pressure Flow Velocity and Column Efficiency What to Optimize in Liquid Chromatography? Ways to Achieve 5000 Plates in 5 Minutes Column Performance at Minimum Inlet Pressure Achievement of Fastest Analyses Practical Considerations Equipment Specifications 4:30 End of Day 3

7 Day 4 FAST LIQUID CHROMATOGRAPHY What is uhplc? Comparison of HPLC vs FIC or UPLC Equipment and column requirements Operating Parameters How to transfer HPLC methods to UPLC LC Method Development Systematic method development approach I Detection conditions First steps in getting the separation Gradient Elution Principals Experimental considerations Validation of Analytical Methods I Why Validate? Objective of method validation Equipment validation IQ, OQ, PQ, Analytical Performance parameters Reverse Phase and Ion Pair Choice of column packing Mobile phase selection Ion suppression Additives for ion pairing Control of ion pairing separations Systematic method development approach: II Solvent Selectivity Solvent optimization RP HPLC Modern HPLC method development using computer-assisted chromatography Which variable to pick? Simulation programs Chemometric Techniques The seven important steps for method developments Live examples 4:30 End of Day 4

8 Day 5 Validation of Analytical Methods II Statistical Approach Linear Regression ANOVA t-test F-test How to use DOE? Considerations for Pharmaceutical Product by QbD Method life cycle Comparison of traditional approaches versus enhanced Bad approaches Risk-based, modern pharmaceutical manufacturing Brief review of ICH Q8, ICH Q9, ICH Q10, ICH Q11 and ICH Q 12 Implementation of Quality by Design in Analytical Method Development AQbD development process How to develop QTMP, how to use risk base tools to link to ATPs Method Performance requirements Quality Risk assessment to Determine criticality of ATP what are the effective risk based tools used developing AQbD elements Factors for identifying a measurement technique Reversed-phase method development workflow Application of AQbD and Risk Assessment for the development of MODR how to establish MODR risk tools used software tools QbD Methodology and Control Strategy The evolution of process understanding Analytical Target Profile, Critical Quality Attributes Process parameters ranking methods Control strategies 4:30 End of Course

9 progamma Science Corporation HPLC Boot Camp Plus Montreal.Canada event /-----/ 2019 Online Opion Best date for me -----/---- / 2019 Please return the completed registration form to: By Mail: By Fax: (514) By Phone: (514) fill this electronic form, save and it to progamma Science Corporation infoteck@progamma.ca 6600 TransCanada, Suite 452, Pointe Claire, Quebec, Canada H9R 4S2 Please Register the : Name: USD Delegate (1): Delegate (2): Delegate (3): Delegate (4): eregistration Form Delegate (5): FREE TOTAL $ Plus tax for Canadians Name: Company : Address : City: State / Province: Postal code / Zip : Telephone : ( ) Fax : ( ) Signature: Method of Payment: Payment endorsed, check is payable to : progamma Science Corporation Please charge my credit card: Please Fax or this form if you are paying with credit card Card Type: Card Number : Expiry Date : Name (as shown on card) : Signature (required) : Venue: Holiday Inn Pointe Claire Authorization # Date: Registration fee: USD , includes the presentation material, lunch and refreshments, for the registered delegate for the complete 3 days. Group discount: Every 4 delegates the fifth is FREE, and if more please contact us. Cancellation/Substitutions: for You must notify us in writing (fax) one week. before the conference date to cancel to receive a refund. No cancellation will be accepted after that date. Notify us by Fax for any substitutions. ASAP. Online option: you will have 21 days to complete the course from time of activation. Payment has to be received before course activation No refund is accepted after activation