FDA Regulations for Analytical Instrument Qualification and Validation – Comprehensive Best Practices

The US Food and Drug Administration (FDA) expect that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. FDA’s findings of deficiencies concerning equipment validation indicate the agency expects definitive evidence that the equipment qualification and validation schedules of a facility will satisfactorily control manufacturing processes. Examples of FDA form 483 findings for equipment qualification and validation indicate a wide range of deficiencies, and compliance is a moving target.

As with most regulatory challenges, 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 90-minute course, you will learn FDA and other global health authority expectations for equipment qualification, along with the development of a sound process validation program, which will allow you to develop and implement bullet-proof solutions that are accepted, effective, and efficient.

Areas Covered in the Session :

• 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
• Be able to 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
• Be able to support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control
• Understand external qualification and validation from a contract manufacturer, and qualification and validation by a supplier
• Develop successful implementation plans
• Perform risk assessments effectively

Who Should Attend:

• Research and Development Departments
• Quality Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments

Course Director: JOY MCELROY

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy 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, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence. Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance. In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off – site training to pharmaceutical and biotech companies throughout the United States. Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.