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Validity : 21st Nov'24 to 01st Dec'24
Analytical Equipment Qualifications, Writing IQ, OQs, and PQs
- Regulatory Requirements and Expectations for Equipment Qualification
1.Europe
2.FDA
3.Global harmonization and expectations
4.Management of Documents, Documents Required
- General Aspects of Qualification
1.Qualification phases, DQ, IQ, OQ, PQ
2.Qualification of existing systems and equipment
3.Requalification/validation - External Equipment Qualification and process Validation
1.Contract manufacture
2.Qualification/validation by a supplier
- Performance of a Process Validation
1.SOPs
2.Writing a process validation protocol
3.Guidelines on Validating Analytical Methods
4.Content and execution
5.Writing the validation plan
6.Methodology and performance
7.Report writing for method validation
8.Presumption for validation
9.Support of Equipment Qualification and Process Validation - Review of FDA Warning Letters
- Case Study Exercise from Current FDA Warning Letters
- Theoretical Case Exercises
- Validation policy
- Performance Qualification
- Presumption for qualification/validation
- Questions
Overview of the webinar
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.
Who should attend?
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Validation engineers
- Manufacturing engineers
- Production engineers
- Design engineers
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
Why should you attend?
- Understand what the global expectations are for equipment qualification and validation
- 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
- Understand and know the principles of auditing the equipment qualification and validation
- 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
- Understand external qualification and validation from a contract manufacturer, and qualification and validation by a supplier
- Support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control
- Understand the documents required for equipment qualification and process validation and how to manage documents appropriately
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 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.
Faculty - Ms.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.