Web Seminar Agenda: | 9:30 – 9:50 | Login & Setup | | 9:50 – 10:00 | Introduction | | 10:00 – 10:40 | Part 1 | | 10:40 – 10:50 | Break | | 10:50 – 11:30 | Part 2 | | 11:30 – 11:50 | Q&A | | 11:50 – 12:00 | Final Thoughts |
Eastern Daylight Time
For a complete pricing structure, please click here Early Bird Deadline: Friday, July 25, 2008
Registration Deadline: Thursday, August 7, 2008
Who Can Benefit: Any pharmaceutical, biotech, medical device, R&D, Discovery Work related to analytical laboratory operations including: QA/QC Management Internal Auditors & Regulatory Affairs Education/Training Managers & Personnel GLP/GMP Compliance Stability Directors, Managers & Supervisors Laboratory Directors, Managers, Supervisors & Scientists Validation Scientists IT/IM Managers & Personnel (Laboratory Instrument & Software Validation) Technical & Analytical Services Metrology Groups Engineering
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Speaker: Johnny Guerra, Ex-FDA
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Laboratory equipment qualification and calibration is more essential now than ever before. Due to the advanced degree of automation, higher sensitivity and the broad dynamic range found in most dedicated scientific instruments, these instruments require an in-depth approach of understanding while performing qualifications such as DQ, IQ, OQ and PQ. This live web seminar covers the impact of qualification procedures in laboratory equipment and instruments for pharmaceutical, biotechnology, GLP, R&D and medical device industries. Participants will learn the basic elements of validation protocols normally expressed as Design, Installation, Operational and Performance Qualifications. Legal requirements under cGMPs and Part 11 (Electronic Records; Electronic Signatures) will be discussed including master qualification protocols, equipment and instrument history file, equipment suitability parameters, calibration requirements, software validation and performance verification. Learning Benefits: Gain a better understanding of the necessary criteria for DQ, IQ, OQ and PQ Identify calibration elements in terms of regulatory compliance as expressed under cGMPs Differentiate between instrument calibration, instrument validation and software validation Identify the requirements to document qualifications for compliance integrity Examine the process of vendor selection Ensure that the qualification and validation documentation complies with FDA audits Define re-validation requirements and when it is necessary Ensure compliance to cGMPs and 21 CFR Part 11 Ensure compliance for data integrity and security requirements
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Areas of Expertise Consulting, Auditing and Training in GMPs and GLPs Failure Investigation, Quality Event and CAPA Certification Programs Company Policy Programs in Human Error Detection, Correction and Prevention Master Certification Programs for Laboratory and Manufacturing Personnel Master Computer Systems Validation (CSV) and Part 11 Certification Programs
Speaker Bio Currently the President of Guerra Consulting Group Inc., Lic. Johnny Guerra spent 20 years working with the FDA, holding such prestigious positions as Acting Science Branch Director and Supervisory Chemist. More>>>
Sponsorship During each webinar, a 15-minute break period will be allotted for companies to promote new products and technologies in today's fast paced environment. More>>>
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