Seminar on Modern Approaches to Process Validation: Requirements for Process Design, Design of Facilities and the Qualification of Equipment and Utilities at Copenhagen, Denmark

Overview:
Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are:
• Company has expertise in its process validation program but can never quite get is arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ),
• Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer
• For systems that employ software and hardware, how does the company manage the validation activities (i.e. through the software validation effort or through the equipment qualification program?
Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.
Why should you attend?
Attend this FDA validation seminar to get deep knowledge about:
• How to define a Sustainable Structure of a Firm's Validation Program
• Understand How Change Control and Other Quality Programs Feed Into the Validation Program
• Offer Usable Protocol and Other Validation Program Document Templates
• Define Minimal Recommended Tests and Verifications for
o Equipment Qualification
o Process Validation
o Software Validation
• Common Pitfalls to Avoid When Executing Validation Protocols
• How to Estimate Costs and Time Associated with Validation
• How to Respond to Customer and Regulatory Audit Observations Associated with Validation
Areas Covered in the Session:
• Basics Of Validation
• The Components of a Sustainable Validation Program
• Other Programs that Feed the Validation Program (1 Hour)
• Equipment, Utility, and Facility Qualification
• Process Validation
• Software Validation
• Time and Costs of Validation
• Responding to Validation and Other Related Audit Findings
Who Will Benefit:
• Internal Auditors
• Regulators
• Legal Departments
• Compliance Officers
• Validation Managers
• QC Managers
• QA Managers
• Facilities and Engineering Department Staff
Agenda:
Day 1 Schedule:
Lecture 1:
Understanding the Basics of Validation
• Regulatory References
• Validation Terminology
Lecture 2:
The Components of a Sustainable Validation Program
• Design Qualification
• FATs and SATs
• Commissioning
• The Validation Master Plan
• The Validation Project Plan
• Standard Operating Procedures (SOPs)
• Protocols
• Reports
• Additional Software Validation Documents
Lecture 3:
Other Programs that Feed the Validation Program
• Change Control
• Complaint Handling
• CAPAs
• Deviation Management
• Maintenance
• Sales

Venue: Hilton Copenhagen Airport
Venue Address: Ellehammersvej 20, Copenhagen, 2770
Date: December 10th & 11th, 2015, Time: 9:00 AM to 6:00 PM
Price: $1,695.00 (Seminar for One Delegate - Without Stay)
&
Price: $2,095.00 (Seminar for One Delegate - With Stay)

Register now and save $200. (Early Bird)
Until November 22, Early Bird Price: $1,695.00 from November 23 to December 08, Regular Price: $1,895.00
Until November 22, Early Bird Price: $2,095.00 from November 23 to December 08, Regular Price: $2,295.00
Quick Contact:
NetZealous DBA as GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/1QrgUT2