Qualification and Validation of Laboratory Equipment and Systems for Regulated Industries

Date	Nov 15, 2018
Time	12:00 AM EDT
Cost	$89050.00
Online

This Seminar will address requirements of both Validation and Qualification activities in Pharma, Biotech and Device Industries, both for compliance to Regulations and industry specific guidelines. More particularly, with respect to Validation of Systems, it will introduce and enumerate a grass roots, basic, iterative pathway to Qualification (IQ, OQ, PQ) of Laboratory Equipment and Validation, which is very portable and widely applicable across the industries. A brief discussion on Qualification of various laboratory instruments and systems will also be touched upon, including current guidance from USP on Analytical Instrument Qualification processes. This Seminar will cover, with illustrations and examples, the various stages in Validation and Qualification of Laboratory Equipment and Systems with a Risk Based Strategy.
 Why You Should Attend:This 2-day Seminar is highly informative and descriptive of the IOPQ Process and what needs to be done for verification of the operational, functional and performance of such equipment and systems. During the Seminar, the attendees will be given a conceptual background of the Qualification and Validation of various instruments, apparatus, devices, computerized systems and equipment from a risk assessment and Product Life Cycle perspective, with several examples, specifications, protocols and SOP requirement stages of deployment and use of various equipment, instruments, etc.
 Areas Covered in the Session:

• Qualification and Validation in Regulated laboratories
• Examples of Regulatory Enforcement Actions
• Risk Based Strategy
• Product Life Cycle and sharing of responsibilities between Vendor and the User
• Integration with Quality System
• Master Validation Plan
• Group Exercise: Develop Qualification Strategy and Master Validation Plan
• Examples of select Equipment /Systems
• Training Issues
• Discussion on guidance from USP on analytical instrument qualification
• Discussion on testing and acceptance criteria

 Who Should Attend:

• Research and Development Departments
• Quality Assurance Departments
• Quality Control Departments
• Validation Departments
• Production Departments
• Process Development Personnel
• Regulatory Departments
• Compliance Departments
• Scientists and Chemists
• Technicians Study Directors (GLP)
• Qualified Persons (EMEA)
• Pharmaceutical Development
• CRO Directors and Managers
• Accredited Laboratories in general
• Everyone engaged with Test Methods

 Why You Should Attend:This 2-day Seminar is highly informative and descriptive of the IOPQ Process and what needs to be done for verification of the operational, functional and performance of such equipment and systems. During the Seminar, the attendees will be given a conceptual background of the Qualification and Validation of various instruments, apparatus, devices, computerized systems and equipment from a risk assessment and Product Life Cycle perspective, with several examples, specifications, protocols and SOP requirement stages of deployment and use of various equipment, instruments, etc.Why You Should Attend:This 2-day Seminar is highly informative and descriptive of the IOPQ Process and what needs to be done for verification of the operational, functional and performance of such equipment and systems. During the Seminar, the attendees will be given a conceptual background of the Qualification and Validation of various instruments, apparatus, devices, computerized systems and equipment from a risk assessment and Product Life Cycle perspective, with several examples, specifications, protocols and SOP requirement stages of deployment and use of various equipment, instruments, etc.