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Applied Statistics for FDA Process Validation 2017

Start Date:
Monday, 18 September, 2017
End Date:
Tuesday, 19 September, 2017 6:00pm
Speciality:
Dermatology, Nephrology, Neurology, Immunology, Pain Management, Hepatology, Cardiology, Endocrinology
Website:
http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901142SEMINAR?meetings4docs-September-2017-SEO

Course "Applied Statistics for FDA Process Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle:Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.The first stage of process validation is process design.

The Process Validation guidance document states, "A successful validation program depends on information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of a manufacturing process that results in products with desired quality attributes: Manufactures should:Understand the sources of variationDetect the presence and degree of variationUnderstand the impact of variation on the process and ultimately on product attributesControl the variation in a manner commensurate with the risk it represents to the process and product."The second stage of process validation is process qualification.

Although stage 2 has two elements, this course will focus on recommendations for the second element, PPQ. PPQ "combines the actual facility, utilities, equipment (each now qualified), and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches." Additionally, the process validation guidance document that "Each manufacturer should judge whether it has gained sufficient understanding to provide a high degree of assurance in its manufacturing process to justify commercial distribution of the product.

Focusing exclusively on qualification efforts without understanding the manufacturing process and associated variations may not lead to adequate assurance of quality."The third stage of process validation is continued process verification. The process validation guidance document defines the need for this stage: "After establishing and confirming the process, manufacturers must maintain the process in a state of control over the life of the process, even as materials, equipment, production environment, personnel, and manufacturing procedures change." Manufacturers should use ongoing programs to collect and analyze product and process data to evaluate the state of control of the process.

These programs may identify process or product problems or opportunities for process improvements that can be evaluated and implemented through some of the activities described in Stages 1 and 2."This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance. It begins with a primer on statistics, focusing on methods that will be applied in each remaining chapter.

Next, it teaches the application of statistics for setting specifications and assessing measurement systems (assays), two foundational requirements for process validation. Lastly, the course applies statistic through the three stages of process validation defined by requirements in the process validation regulatory guidance documents. Methods taught through all three stages are recommended by regulatory guidance documents; references to the specific citations in the guidance documents are provided.

Why should you attend: The Food and Drug Administration (FDA) provided a guidance for industry in 2011 that has established a framework for process validation in the pharmaceutical industry. This guidance, titled "Process Validation: General Principles and Practices" consists of a three-stage process. The three stages are 1) Process Design, 2) Process Qualification, and 3) Continued Process Verification.This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process development and validation program consistent with the FDA guidance.

This course teaches the application of statistics for setting specifications, assessing measurement systems (assays), using design of experiments (DOE), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.Although established for the pharmaceutical industry, it also provides a useful framework for other industries.Analyses in this course use the point-and-click interface of JMP software by SAS.

Areas Covered in the Session: apply statistics to set specifications and validate measurement systems (assays)develop appropriate sample plans based on confidence and powerimplement suitable statistical methods into a process validation program for each of the three stagesStage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQStage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

Who Will Benefit: This seminar is designed for pharmaceutical and biopharmaceutical professionals who are involved with product and/or process design, validation, or manufacturing/control.Process Scientist/EngineerDesign EngineerProduct Development EngineerRegulatory/Compliance ProfessionalDesign Controls EngineerSix Sigma Green BeltSix Sigma Black BeltContinuous Improvement Manager Agenda: Day 1 Schedule Lecture 1:Introduction to Statistics for Process Validationprinciples of process validationstages of process validationPrimer on Statistical Analysisbasic statisticsLecture 2:Primer on Statistical Analysis (cont.)statistical intervals and hypothesis testingLecture 3:Primer on Statistical Analysis (cont.)statistical intervals and hypothesis testingANOVALecture 4:Primer on Statistical Analysis (cont.)regressionrun charts Day 2 Schedule Lecture 1:Foundational Requirements for Process Validationsetting specificationsanalytical methodologyStage 1 - Process Designsteps to DOEscreening designsLecture 2:Stage 1 - Process Designresponse surface designsestablishing a strategy for process qualificationLecture 3:Stage 2 - Process Qualificationintroductionincorporation of large-scale datadevelopment of PPQ acceptance criteriadevelopment of sampling plansLecture 4:Stage 3 - Continued Process Verificationstatistical process controlprocess capability Speaker:Richard (Rick) K.

Burdick Richard (Rick) K. Burdick is an Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc. for 10 years. He taught at ASU for 29 years at all levels including undergraduate business students, MBAs, Master of Statistics students, and doctoral candidates in both business and engineering. He received numerous teaching awards and taught a variety of courses for adult learners.

His research and consulting interests consider several CMC statistical applications including comparability studies, stability data analysis, analytical method validation, quality by design process characterization, and analytical similarity for biosimilar products. He has written over 60 journal articles and three books, including Confidence Intervals for Random and Mixed ANOVA Models with Applications to Gauge R&R Studies, (with C.

M. Borror and D. C. Montgomery) and Confidence Intervals on Variance Components, (with F. A. Graybill). Burdick is a Fellow of the American Statistical Association and a member of the American Society for Quality. He has served on the USP Statistics Expert Committee since 2010. He received his Bachelor's Degree in Statistics from the University of Wyoming. He received his Masters and Doctorate degrees in Statistics from Texas A&M University.

Location: Baltimore, MD Date: September 18th & 19th, 2017 and Time: 9:00 AM to 6:00 PMVenue: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090Price: Register now and save $200. (Early Bird)Price: $1,295.00 (Seminar Fee for One Delegate)Until August 10, Early Bird Price: $1,295.00 From August 11 to September 16, Regular Price: $1,495.00 Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* 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 Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}

Location

The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum,
Maryland,
21090

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

Address:
NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
Phone:
Event Manager
Email:
john.robinson@globalcompliancepanel.com

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