2011 - How to get the most out of Supplier Support for Equipment and Computer Validation

This seminar will discuss how regulated user firms can reduce validation costs and how suppliers can increase business

Why to attend:

FDA's and industry task forces recommend leveraging vendor support for equipment qualification and computer system validation. For example GAMP 5 states: "Although the responsibility for compliance with GxP regulations lies with the regulated company, the supplier may have considerable involvement in the process" Regulated companies are unsure what and how much validation support they can expect and ask for, suppliers on the other hand are unsure what the exact expectations of the regulated users are. The seminar has all the answers.

Areas Covered in the Seminar:

* Responsibilities of vendors and users for equipment qualification and software validation
* FDA and international requirements for supplier/user agreements
* Criteria for selecting the right supplier for regulated environments
* Claims vendors can make about software compliance
* What suppliers should offer to regulated users
* What regulated users should expect from suppliers
* Help during design qualification of equipment and compute
* Assistance for supplier assessment
* Contribution during installation
* Help for operational qualification and requalification
* Leveraging suppliers hardware and software testing for users tests
* 10 reasons why operational qualification is performed by suppliers
* The importance of vendor services for (preventive) maintenance
* Documents that should be provided by the supplier

Date: November 17,2011
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide (oder USA, nicht Germany, fall das möglich ist)

Who should attend
* Marketing professionals of equipment and computer system supplier
* QA managers and personnel
* IT managers and personnel
* Validation specialists
* Regulatory affairs
* Consultants
* Purchasers of equipment and computer systems
* Software development engineers
* Documentation department

Weblink: http://www.labcompliance.com/seminars/audio/278/de...

Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, FDA, validation