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Réf : 26010
Evènement :Design of Experiments and Statistical Process Control for Process Development and Validation 2017

Dates :Jeudi 16 Novembre 2017 - Vendredi 17 Novembre 2017

Lieu :Kuala Lumpur, Malaysia
Kuala Lumpur, Malaysia
Kuala Lumpur, Malaysia, États-Unis

Type :Formation - Audience Internationale

Accréditation :--


 

Informations

Course "Design of Experiments and Statistical Process Control for Process Development and Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

               

Overview:

 

This course will present the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. A practical approach with case studies and examples will be used, with theoretical information introduced only when necessary to understand an experiment. Examples from real processes and testing procedures will be used to present the student with examples that will be directly applicable to their work.

 

Why you should attend:

 

Any pharmaceutical worker who performs, supervises or reviews manufacturing or testing processes needs to understand the relationships among the process parameters and be able to monitor the performance of processes and test methods. This is particularly true for the worker in Quality Control and Quality Assurance as the recent FDA guidance document on Process Validation has assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit. The work, however, is done by the development, manufacturing, or quality systems worker who should also attend this course to learn how to design the systems and studies, and interpret the results generated.

 

Who will benefit:

 

  • Directors
  • Managers
  • Supervisors
  • Lead workers in Process Development
  • Manufacturing
  • Regulatory Affairs
  • Quality Assurance and Quality Control
  • Workers who will be participating in operations or the supervision of the development, manufacturing, or testing of medicinal products will benefit from knowing the procedures and applications of DOE and SPC.

 

Agenda:

Day 1 Schedule

 

Dietary Design of Experiments

Lecture 1:

Introduction

  • Input/Output, CPP and CQA, what are they?
    • Defining the CPP and CQA for a process
    • Defining the design space
  • Snedecor's F-test and ANOVA

Lecture 2:

One Level, One Factor Designs. Simple Comparisons.

  • The simplest form of the full F-test.
  • A one factor ANOVA with multiple treatments
    • The least significant difference (LSD)
  • The use of blocking in a one factor experiment.

Lecture 3:

Two-Level Multi-factorial Design

  • Description of the experiment
    • Conversion to the standard form with results of testing
  • Definition of an Orthogonal Array
  • Interactions in the array
  • Effects (Contrasts) in the array.

Lecture 4:

Extracting Information from the Experiment

  • Use of a Half-normal Plot.
  • What about the second set of test data?
  • Using the effects for a Pareto Chart
  • Interpreting the interactions for process design

 

Day 2 Schedule

 

Statistical Process Control

 

Lecture 1:

Shewhart Charts for Variable Data

  • Classical X-bar and R-bar charts
  • Estimating control limits for early studies
  • Significance of events using the "Western Electric Rules."

Lecture 2:

Shewhart Charts for Attribute Data Especially Counts.

  • p and np charts for attributes.
    • Handling binomially distributed data.
  • c charts and u charts for non-conformities
  • Handling binomially distributed data.

Lecture 3:

Considerations from Shewhart Charts

  • Rational subgroups.
  • Setting the process capability indices.
  • Coupling as a problem

Lecture 4:

Other Types of Charts Related to Shewhart Charts

  • Moving average chart
  • Exponentially weighted chart
  • CUSUM chart

 

 

Speaker

 

Dr. Steven Kuwahara

Founder & Principal, GXP Biotechnology, LLC

 

Dr. Steven Kuwahara, Ph.D. is the Founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.

 

 

 Location: Kuala Lumpur, Malaysia Date:  November 16th & 17th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON , Kuala Lumpur, Malaysia

 

Price:

 

Price: $895.00 (Seminar Fee for One Delegate)

Register for 5 attendees   Price: $2,685.00   $4,475.00 You Save: $1,790.00 (40%)*

Register now and save $200. (Early Bird)

Until October 10, Early Bird Price: $895.00 From October 11 to November 14, Regular Price: $1,095.00

Register for 10 attendees   Price: $4,922.00  $8,950.00 You Save: $4,028.00 (45%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901327SEMINAR?doctorama-November-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

Lieu

Plan et itinéraire
Adresse de la formation :
Kuala Lumpur, Malaysia
Kuala Lumpur, Malaysia
Kuala Lumpur, Malaysia
États-Unis
Tél : 800-447-9407
Plan et itinéraire

Renseignements

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Annonceur

GlobalCompliancePanel
GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and [...]

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Design of Experiments and Statistical Process Control for Process Development and Validation 2017 Médecine - Pharmacie
design of experiments examples, design of experiments statistics, multifactor design of experiments software, design of experiments training, design of experiments analysis, taguchi methods design of experiments examples, manufacturing design courses, design & manufacturing event
Professionnels, Directors Managers Supervisors Lead workers in Process Development Manufacturing Regulatory Affairs Quality Assurance and Quality Control Workers who will be participating in operations or the supervision of the development, Manufacturing, Or testing of medicinal products will benefit from knowing the procedures and applications of DOE and SPC.
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