"Quality by Design" : DoE | QbD | SPC INTERNATIONAL Online Hands-On Practical Training Workshop from 13th October-16th October 2022.

QbD-Expert™ is organizing International 4-Days 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 13th October, 2022 to 16th October, 2022 [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 Early Bird Discounted Registration is 24th September, 2022. 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 qbdexpert@gmail.com