Basic Design of Experiments


Thursday, February 28, 2019   |   10:00 AM PST | 01:00 PM EST   |   Duration: 90 Minutes      

Live

One Dial-in One Attendee

Price: US$150.00


Corporate Live

Any number of participants

Price:US$290.00


Duration: 90 Minutes  

Recorded

Access recorded version,
only for one participant ?

Price: US$190.00

Corporate Recorded

Access recorded version,
Any number of participants ?

Price: US$390.00

The webinar will touch on the tools used to generate the data as well as how to use tools to determine which parameters to vary, The resultant data are used to construct a Design Space, A successful QbD program cannot be done without a well-designed DoE.

Emil W Ciurczak   Product Id : 502346
  Instructor : Emil W Ciurczak

  More Trainings by this Expert


Overview:

Traditional batch processing is time-consuming and expensive to perform. With intermediate steps being stored until the following step. A batch not only takes weeks to produce, but there is no control of the process under current GMP. To enhance the control (and the quality) of products, the USFDA issued several Guidances, covering PAT and QbD.

Under cGMP, no changes in a process may be made during a process; under QbD, appropriate steps may be taken to ensure a quality batch. To perform QbD, the operators need scientifically valid reasons to make adjustments, within a "Design Space".

The webinar will touch on the tools used to generate the data as well as how to use tools to determine which parameters to vary. The resultant data are used to construct a Design Space.

Why should you Attend: With PAT (process analytical technologies) and QbD (quality by design) becoming more the norm than batch processing, choosing the correct parameters within which adjustments may be made is imperative. The "safe zone" of settings (for a quality product) is named "Design Space".

Design space is determined by performing a series of carefully designed experiments; calculated, controlled changes in parts of the process (ingredient ratios, compression force and speed, etc.) are made in a pre-designed pattern.

The math involved with designing the minimum, yet sufficient number of changes and the program(s) used to interpret the quality of the resultant products and which parameter(s) are the most important to control (CPP - critical process parameters)

A successful QbD program cannot be done without a well-designed DoE

Areas Covered in the Session:

  • Choosing parameters to vary by risk assessment software
  • Determining potential parameters to vary
  • Choosing the correct design of the experiment
  • Evaluating the data
  • Building and applying the resultant Design Space

Who Will Benefit:
  • Managers in Production
  • Formulators
  • AR&D Personnel
  • QA/QC Personnel


Speaker Profile
Emil W. Ciurczak has been working with NIR for over 35 years. He is the co-editor of the "Handbook of Near-Infrared Analysis" (4th ed in prep) and co-author of "Pharmaceutical and Medical Applications of NIR Spectroscopy" (1st, 2nd editions). He has over 100 refereed publications and over 350 presented papers on the subject and is a Contributing Editor to Pharmaceutical Manufacturing and Contract Pharma magazines (over 450 columns).

He has been teaching NIR/Raman, PAT, QbD, and Design of Experiment for various organizations since 1988 in the US, Asia, South America, and Europe. He has almost 50 years of pharmaceutical experience and has taught various chemistry courses at the college level since 1979. He holds twelve patents for NIR hardware and software.

He won the 2004 EAS "Achievements in NIR" award was a member of the FDA's subcommittee on PAT in 2002. Emil has worked for Ciba-Geigy, Merck, Sandoz, and Purdue Pharma in addition to working with several NIR instrument manufacturers in his career, and currently consults for Pharma companies and instrument manufacturers.




Your Recently Viewed Webinars

Payment Methods

Contact Us

NetZealous LLC,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

Information

  Refund Policy
  +1-800-447-9407
  Fax: 302 288 6884
  support@compliance4All.com