Analytical Instrument and Equipment Qualification in GXP and EPA Laboratories: USP 1058 and Beyond

The impact of USP <1058> on analytical instrument qualification will be reviewed and the newest regulation will be presented in a simple and understandable way. The interaction of calibration, qualification, method validation and equipment maintenance on laboratory compliance and data quality will be discussed.

Areas Covered in the seminar:

• Regulatory requirements for analytical instrument qualification.
• Calibration and Metrology Programs.
• USP <1058>.
• ICH Q2.
• GXP.
• Equipment and Instruments - similarities and differences.
• Standards and Traceability.
• Documentation of instrument qualification.

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and data systems will also benefit.

The employees who will benefit include: End-users responsible for testing

• QA managers and validation personnel
• Analytical development managers and personnel
• Senior Quality, Facilities and R&D Management
• Quality Control staff
• Quality system auditors

Instructor Profile:

Rich Poser, is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the vendors such as contract laboratories, instrument manufacturers, contract manufacturing sites and software developers that support these highly regulated industries.

Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. Following work in product development, laboratory automation, and validation and quality systems for the Mylan Pharmaceutical Company, Rich joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. After the acquisition of Dura by Élan, Rich was appointed Director of Quality Laboratory Operations and led their 21CFR Part 11 training and audit team.

Now in private practice as a quality consultant, he also lectures at UCSD Extension in validation, cGMP Regulations and analytical methods validation, and has presented or chaired public seminars on cGMP Requirements, Computer System Validation, Vendor Qualification Auditing, Analytical Methods Validation and Infrastructure Qualification.

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