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 you 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 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 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.
Upon completing this course participants should:
o Global harmonization and expectations
o Validation Policy
o Validation Master Plan (VMP)
o Documents Equipment Qualification
o Validation Team
o Presumption for Qualification/Validation
o Qualification Phases, DQ, IQ, OQ, PQ
o Qualification of existing systems and equipment
o Writing a qualification protocol, content
o Executing a qualification
o Tests, and data
o Writing a qualification final report
o Writing a Process validation protocol
o Content and execution
o Writing the validation plan
o Methodology and performance
o Report writing for method validation
o Presumption for validation
o Support of Equipment Qualification and Process Validation
o Quality Management System
o Risk Analysis
o Change Control
o Auditing equipment qualification and process validation
o External Equipment Qualification and process Validation
o Contract Manufacturer
o Qualification/Validation by a supplier
o Review of FDA warning letters
o Case Study Exercise from current FDA Warning Letters
o Theoretical Case exercises
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.
What You Get:
Joy L. 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.