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Regulatory Requirements Cleaning Validation | FDA Guidelines 2018

Regulatory Requirements Cleaning Validation | FDA Guidelines 2018

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Who should attend?

Senior Quality Managers Quality Professionals Production Supervisors Validation Engineers Process Owners Quality Engineers Quality Auditors

Details

Course "Regulatory Requirements and Principles for Cleaning 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 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 you should attend:

 

Attendance at 2day 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: Zurich, Switzerland Date:  March 8th & 9th 2018 and Time: 9:00 AM to 6:00 PM

 

Venue:  Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

 

 Price:

Register now and save $200. (Early Bird)

Price: $1,695.00 (Seminar Fee for One Delegate)

Until January 20, Early Bird Price: $1,695.00 From January 21 to March 06, Regular Price: $1,895.00

Register for 5 attendees   Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

Register for 10 attendees   Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*

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 - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901285SEMINAR?pharmiweb-March-2018-SEO

 

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Prices

Price: $1,895.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $5,685.00 $9,475.00 You Save: $3,790.00 (40%)* Register for 10 attendees Price: $10,422.00 $18,950.00 You Save: $8,528.00 (45%)*

Contact

Event Manager
john.robinson@globalcompliancepanel.com

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