This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP).
The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
The FDA's Quality System Regulation (QSR) is clear on the importance of equipment controls - you must have and follow procedures for installing, operating and maintaining all equipment used in your manufacturing processes. And that includes any ancillary equipment that affects production, such as environmental systems and contamination controls.
Learning Objectives:
- Understand what the global expectations are for equipment qualification and validation
- Understand the documents required for equipment qualification and process validation and how to manage documents appropriately
- Understand and know how to write and maintain a Validation Master Plan
- Write and execute sound protocols for equipment qualification (IQ, OQ, PQ) and process validation
- Qualify already existing systems and requalification
- Be able to collect data, conduct tests, and obtain all necessary documents
- Understand the different types of validation
- Understand performance validation
- Know the guidelines on validating analytical methods and processes
- Support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control
- Understand and know the principles of auditing the equipment qualification and validation
- Understand external qualification and validation from a contract manufacturer, and qualification and validation by a supplier
- To investigate true root causes of problems and to evaluate and prioritize solutions
- Problem solving methods to help you asses which is best for your situation
- Develop successful implementation plans
- Perform risk assessments effectively
Why Should You Attend:
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.
The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for equipment qualification and validation in your manufacturing facility?
In this webinar, participants will learn the different global agencies' expectations of 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, the course 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 management practices of your equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from non-conformance with regulators and auditors.
Areas Covered
- Regulatory Requirements and Expectations for Equipment Qualification
- Europe
- FDA
- Global harmonization and expectations
- Management of Documents, Documents Required
- Validation policy
- Validation Master Plan (VMP)
- Documents equipment qualification
- SOPs
- Responsibilities
- Validation team
- Presumption for qualification/validation
- General Aspects of Qualification
- Qualification phases, DQ, IQ, OQ, PQ
- Qualification of existing systems and equipment
- Requalification/validation
- Performance Qualification
- SOPs
- Writing a qualification protocol, content
- Executing a qualification
- Tests and data
- Documents
- Writing a qualification final report
- Questions
- Performance of a Process Validation
- SOPs
- Writing a process validation protocol
- Guidelines on Validating Analytical Methods
- 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
Instructor Profile:
Upon earning a degree in Zoology from North Carolina State University, Joy McElroy 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.
In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.
With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.