In the last couple of years USP 1058 became the global golden standard for analytical instrument qualification.
The principle has also been applied for all laboratory equipment qualification and calibration. FDA and international inspectors refer to its qualification principles for GMP assessment of laboratory equipment. But still today companies struggle with implementation because 1058 is an excellent high level document does not really give specific advice on 'how to' qualify analytical instruments. Attendees not only will lear how to effectively apply USP 1058 for all laboratory equipment, they also will reaceive 10+ best practice guides for easy implementatiion.
Areas Covered in the Seminar:
* FDA and EU laboratory equipment requirements
* Most common inspection problems
* Terminology, scope and principles of US chapter 1058.
* Extending the scope of the 4Q model to all laboratory equipment
* Qualification compared to method validation and system suitability testing
* Essential steps for laboratory equipment qualification : DQ, IQ, OQ, PQ
* Allocation of instruments to the three categories A, B and C
* Procedures and validation deliverables for the three categories
* Recommendations for firmware and software validation
* Integrating equipment and computers to system validation
* Roles and responsibilities:
* Qualification of existing systems
* Requalification after equipment changes (move, repair, firmware upgrade)
* Recommendations for effective implementation
* The future of 1058: Proposed changes
And for easy and instant implementation:
download 10+ documents from special seminar website.
They include
* SOP: Analytical Instrument Qualification for 1058
* SOP: Allocating Analytical Instruments to USP 1058 categories
* SOP: Qualification of equipment
* SOP: Qualification of Laboratory Equipment
* Qualification examples from beginning to end (DQ, IQ, OQ, PQ)
* FDA Presentation on Equipment Qualification, includes acceptance criteria
* Reference Article: Parameters and limits for operational qualification
* USP presentation:
Date: September 27,2012
Time: 11.00 - 12.00 a.m. EDT
Location: Online, worldwide
Who should attend
* Laboratory managers and staff
* QA managers and personnel
* Metrology groups
* Validation groups
* Analysts
* Regulatory affairs
* Training departments
* Documentation department
* Consultants
Weblink: http://www.labcompliance.com/
Presenter: Dr. Ludwig Huber
Category: Pharmaceutical, API Manufactuer, FDA, Change Control
