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 letters
Who 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
Agenda
Day One:Lecture 1:
Requirements and approaches for Analytical Instrument Qualification
Going through the qualification phases
Lecture 2:
Testing and deviation handling
Retrospective qualification and Requalification
Lecture 3:
Equipment Maintenance and Change control
Type and extend of qualification for USP Instrument Categories
Lecture 4:
Requirements and approaches for Laboratory Computer Systems
Day Two:
Lecture 1:
Requirements and approaches for Laboratory Computer System
Lecture 2:
Validation of Laboratory Computer systems
Validation and Use of Excel in the QC Laboratory
Lecture 3:
Periodic review and revalidation of chromatographic data system
Handling raw data and other laboratory records
Ensuring Integrity and Security of Laboratory (Raw) data
Lecture 4: Auditing Laboratory Computer Systems and records for FDA Compliance
Speaker:
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, MA
Date: May 5th & 6th, 2016 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Price Details:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar for One Delegate)
Until March 31, Early Bird Price: $1,295.00 from April 1 to May 3, Regular Price: $1,495.00
Quick Contact:
NetZealous DBA as MentorHealth
Phone: 1-800-385-1607
Email: support@mentorhealth.com
Website: 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
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 letters
Who 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
Agenda
Day One:Lecture 1:
Requirements and approaches for Analytical Instrument Qualification
Going through the qualification phases
Lecture 2:
Testing and deviation handling
Retrospective qualification and Requalification
Lecture 3:
Equipment Maintenance and Change control
Type and extend of qualification for USP Instrument Categories
Lecture 4:
Requirements and approaches for Laboratory Computer Systems
Day Two:
Lecture 1:
Requirements and approaches for Laboratory Computer System
Lecture 2:
Validation of Laboratory Computer systems
Validation and Use of Excel in the QC Laboratory
Lecture 3:
Periodic review and revalidation of chromatographic data system
Handling raw data and other laboratory records
Ensuring Integrity and Security of Laboratory (Raw) data
Lecture 4: Auditing Laboratory Computer Systems and records for FDA Compliance
Speaker:
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, MA
Date: May 5th & 6th, 2016 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Price Details:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar for One Delegate)
Until March 31, Early Bird Price: $1,295.00 from April 1 to May 3, Regular Price: $1,495.00
Quick Contact:
NetZealous DBA as MentorHealth
Phone: 1-800-385-1607
Email: support@mentorhealth.com
Website: 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
