The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. The FDA’s findings of deficiencies concerning equipment validation indicate the agencies expect definitive evidence that the equipment qualification and validation schedules of a facility will satisfactorily control their manufacturing processes. Examples of FDA form 483 findings for equipment qualification and validation indicate deficiencies in many of these studies.
Upon completing this course participants should:
· Europe
· FDA
· Global harmonization and expectations
· Validation Policy
· Validation Master Plan (VMP)
· Documents Equipment Qualification
· SOPs
· Responsibilities
· Validation Team
· Presumption for Qualification/Validation
· Qualification Phases, DQ, IQ, OQ, PQ
· Qualification of existing systems and equipment
· Requalification/Validation
· SOPs
· Writing a qualification protocol, content
· Executing a qualification
· Tests, and data
· Documents
· Writing a qualification final report
· Questions
· SOPs
· Writing a Process validation protocol
· Content and execution
· SOPs
· Writing the validation plan
· Methodology and performance
· Report writing for method validation
· Presumption for validation
· Support of Equipment Qualification and Process Validation
· Quality Management System
· Risk Analysis
· Calibration/Maintenance
· Change Control
· Auditing equipment qualification and process validation
· External Equipment Qualification and Process Validation
· Contract Manufacturer
· Qualification/Validation by a supplier
· Review of FDA warning letters
· Case Study Exercise from current FDA Warning Letters
· Theoretical Case exercises
· Questions
This is a practical webinar designed to provide pharmaceutical, bio-pharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection. The course is ideal for Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance.
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.