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32801 Conferences

FDA Process Validation for Applied Statistics 2017

Added by globalcompliancepanel on 2017-05-10

Conference Dates:

Start Date Start Date: 2017-07-20
Last Date Last Day: 2017-07-21
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2017-07-18

Conference Contact Info:

Contact Person Contact Person: Event Manager
Email Email: john.robinson@globalcompliancepanel.com
Address Address: Four Points by Sheraton Chicago O, Chicago, IL, 60176, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

Understand the sources of variation
• Detect the presence and degree of variation
• Understand the impact of variation on the process and ultimately on product attributes
• Control 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 states 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.


Location: Chicago, IL Date: July 20th & 21st, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Four Points by Sheraton Chicago O'Hare
Address: 10249 W Irving Park Road, Schiller Park, IL 60176, United States
Price:

Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until June 10, Early Bird Price: $1,295.00 From June 11 to July 25, 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 “FDA Process Validation” seminar
At this seminar, world-renowned FDA Process Validation subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Process Validation and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Process Validation 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/co ntrol/sponsorship

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.co m
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/con trol/globalseminars/~product_id=901012SE MINAR?worldconferencecalendar_july_2017_ SEO
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