"Quality by Design" : DoE | QbD | SPC INTERNATIONAL Hands-On Online Practical Training Workshop from 24th May to 27th May 2023

QbD-Expert??is organizing?International?4-Days Hands-On Online Practical Training Workshop?of?"QUALITY BY DESIGN (QbD)"?– For Practical Implementation of tools & tactics of QbD & Six Sigma (6σ) for Pharmaceutical Product Development?for participant staying in any country of the world?from?24th May, 2023 to 27th May, 2023?[7:30 PM to 11:55 PM Indian Standard Time (IST)].?The Course Work of this QbD training workshop has been designed. in line with ICH Q8(R2),?Q9, Q10, Q11, Q12, Q13, Q14, Six Sigma DMADV & DMAIC?& Kaizen for?Industry?Scientists, Technocrats & Project Managers and?Academic?Research Scholars, Lecturers & Professors?belonging to Formulation Development, Analytical Development, Packaging Development, Drug Regulatory Affairs, Manufacturing, Quality Assurance departments.

This?Quality by Design (QbD)?Online Practical Training Workshop is scheduled into?4 days:??

(a)?1st & 2nd Day?:?Training of all 6 Modules of QbD?(1. Define & Project, 2. Determine & Measure, 3. Analyze & Evaluate, 4. Design & Develop, 5. Verify & Control & 6. Continue & Improve) with 24 Advanced Tools?of Quality by Design (QbD) & Six Sigma (6σ), i.e.?Customer Voice Recorder, Impact Analyzer, Risk Matrix Analyzer, FMEA-RPN Analyzer, Pareto Chart Generator,?Scale-Up Factors Calculators,?DoE Design Selector & Generator, Regression Model Analyzer, Graphical Optimizer, Numerical Optimizer, Design Space Developer,?Pp/Ppk Calculators, PPF Control Strategy Implementer, Continuous Process Verifier, Control Charts Selector & Trend Analyzer, Cp/ Cpk Calculators, Process Sigma Calculator;??

(b)?3rd & 4th Day?:?Practical Workshop covers various?Formulation & Process DoE | QbD | SPC?Case Studies for designing of different dosage forms i.e.?

(i) DoE | QbD | SPC for?Solid Orals?– IR & MR Tablets, Hard Gelatin Capsules, Soft Gelatin Capsules;?

(ii) DoE | QbD | SPC?for?Liquid Orals?– Solution, Suspension, Emulsion;?(iii)?DoE | QbD | SPC?for Semisolid?Topicals??– Cream, Ointment / Paste, Gel;?

(iv)?DoE | QbD | SPC?for?Parenterals?– Injections & Infusion Dosage Forms;

along with?API QbD,?Analytical QbD?&?Packaging QbD

This?PRACTICAL?Workshop?with 101?CASE STUDIES?will be conducted in line with theoretical training modules on standard softwares meant for Design of Experiments / Statistical Process Control??i.e.?Design-Expert? & Minitab?, So R&D Scientists will get hands-on training for handling softwares for eCTD ANDA / MAA?Product Development Report?Dossier Preparation for US FDA, EU EMA & Japan PMDA

Registration also include?Standard?COURSE MATERIAL?for QbD which comprising of: 1.?QbD Models?- Presentation Handouts 2.?QbD?- Quality by Design Master Guide (D|M|A|D|I|V|C|I) 3.?DoE?- Design of Experiments Master Guides & Manuals (D|M|A|D|V) 4.?SPC?- Statistical Process Control Master Guides & Manuals (D|M|A|I|C) 5.?House of Quality (HOQ)?– QTPP Determination Template 6.?Critical to Quality (CTQ) Tree?Template for IP & FP CQAs 7.?SIPOC Process Mapping?Template for Risk Identification 8.?Cause & Effect Ishikawa Fishbone?Diagram Template??9.?RRMA?- Relative Risk Matrix Analysis Risk Assessment Templates 10.?FMEA?- Failure Modes Effects Analysis Risk Assessment Templates 11.?DoE Screening?Design Templates - Design-Expert? 12.?DoE Optimization?Design Templates - Design-Expert? 13.?SPC Variable?Charts Templates - Minitab? for I-mR, X-mR, Xbar-R, Xbar-S Charts 14.?SPC Attribute?Charts Templates - Minitab? for p-chart, np-chart, c-chart, u-charts 15.?Scale Up Factors?Calculators for different Manufacturing Processes for Solid orals, Liquid Orals, Topicals & Parenterals 16.?IVIVC Correlation & Prediction?Analysis Templates??17.?Dissolution Data Modeling?(Zero Order, First Order, Hixson–Crowell, Weibull, Higuchi, Baker–Lonsdale, Korsmeyer–Peppas & Hopfenberg) 18.?Dissolution Profile Comparison?(Pairwise Procedure: (f1, f2, Rescigno indices), 90% CI of difference, MSD, Bootstrap f2, Chow & Ki’s time series)?

At the end of this QbD online training-workshop, each participant will be awarded with?QR encoded?e-Certificate?for this 4-Days?QbD Online Training Workshop from QbD-Expert?

QbD-Expert also provide?post-event?whatsapp & email assistance services to all the registered participants for any of their QbD based Project related queries

Last Date?for?Registration?is?23rd May, 2023.?This is a?unique 4 Days QbD Online Training Workshop, as it has involved all the theoretical?modules?& practical applications of DoE / QbD, SPC / 6σ?& Kaizen tools ! So,?Don't miss this?Golden?Opportunity !

For registration, Please?contact us?on?+91 8866327899 or?whatsapp?us on +91 9904474045 or?email us?on?[email protected]??