Seminar on Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audi
- Start Date:
- Thursday, 5 May, 2016
- End Date:
- Friday, 6 May, 2016 6:00pm
- Internal Medicine, Emergency Medicine, Business Practice, Health & Nutrition
Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.Overview:In this two day workshop conference you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient.
Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors.This seminar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audits and how to become part 11 compliant.Why should you attend?The cost of non-compliance is therefore more than that of compliance.
Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility?Areas Covered in the Session:· Learn about the regulatory background and requirements for laboratory instrument qualification and system validation· Understand the logic and principles of instrument qualification and system validation from validation planning reporting· Understand and be able to explain your company's qualification and validation strategies· Be able to independently prepare execute test protocols, this includes setting specifications and acceptance criteria· Understand how to review and approve qualification and validation protocols· Be able to develop inspection ready qualification and validation deliverables· Learn how to avoid and/or respond to FDA inspectional observations and warning lettersWho Will Benefit:This seminar will be beneficial personnel in pharmaceutical development and quality control laboratories and contract testing laboratories as well as Individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance specifically related to equipment and processes.
Following personnel will benefit from the course· Laboratory managers, supervisors and analysts· IT managers and staff· Consultants· Laboratory suppliers of material, equipment and services· Senior quality managers· Quality professionals· Regulatory professionals· Compliance professionals· Production supervisors· Validation engineers· Manufacturing engineers· Production engineers· Design engineers· Process owners· Quality engineers· Quality auditors AgendaDay One:Lecture 1:Requirements and approaches for Analytical Instrument QualificationGoing through the qualification phasesLecture 2:Testing and deviation handlingRetrospective qualification and RequalificationLecture 3:Equipment Maintenance and Change controlType and extend of qualification for USP Instrument CategoriesLecture 4:Requirements and approaches for Laboratory Computer SystemsDay Two:Lecture 1:Requirements and approaches for Laboratory Computer SystemLecture 2:Validation of Laboratory Computer systemsValidation and Use of Excel in the QC LaboratoryLecture 3:Periodic review and revalidation of chromatographic data systemHandling raw data and other laboratory recordsEnsuring Integrity and Security of Laboratory (Raw) dataLecture 4:Auditing Laboratory Computer Systems and records for FDA ComplianceSpeaker:Joy McElroyPrinciple Consultant at Maynard Consulting Company Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing.
Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.Now with 12 years' experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.Joy specializes in Equipment Qualification, Cleaning Validation, Sterilization, Environmental Monitoring, and GMP Compliance Auditing.Location: Boston, MADate:May 5th & 6th, 2016and Time: 9:00 AM to 6:00 PM Venue:WILL BE ANNOUNCED SOON, Boston, MA Price Details: Price: $1,495.00 (Seminar for One Delegate) Quick Contact:NetZealous DBA as MentorHealthPhone: 1-800-385-1607Email: email@example.comWebsite: http://www.mentorhealth.com/ Registration Link - http://www.mentorhealth.com/control/globalseminars/~product_id=200060SEMINAR Follows us:Twitter: https://twitter.com/MentorHealth1 LinkedIn: https://www.linkedin.com/company/mentorhealth
Conference organized by Netzealous -MentorHealth
MentorHealth is a comprehensive training source for healthcare professionals. Our trainings are high on value, but not on cost. MentorHealth is the right training solution for healthcare professionals. With MentorHealth, healthcare professionals can make use of the best benefits relating to their professional training. • They can get the benefit of advice from experts in the field. • Healthcare professionals will have the flexibility of viewing recorded webinars at their convenience.• MentorHealth offers online interactive participation. Using this, healthcare professionals, no matter which part of the world they are based in, will have the opportunity to listen to and interact with some of the most accomplished experts in the healthcare Industry.
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