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Event
21 Apr 2016
Health

Requirements for Establishing an Effective Cleaning Validation Program

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning.

Overview: This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan" and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.Why should you attend?Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.Location: San Diego, CA Date: April 21st & 22nd 2016 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOONPrice: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar for One Delegate) Until March 20, Early Bird Price: $1,295.00 from March 21 to April 19, Regular Price: $1,495.00Quick Contact:NetZealous DBA as GlobalCompliancePanel  Phone: 1-800-447-9407Fax: 302-288-6884

When

21 Apr 2016 @ 09:00 am

22 Apr 2016 @ 06:00 pm

Duration: 1 days, 9 hours


Where

WILL BE ANNOUNCED SOON

San Diego

United States


Language

English en


Organised by

GlobalCompliancePanel (deactivated)