ComplianceOnline

Course Description:

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 two day workshop conference 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 nonconformance with regulators and Auditors.



Learning Objectives:

Upon completing this course participants should:

  • 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


Who Will Benefit:

This course is designed for people tasked with developing, maintaining and/or improving equipment qualification programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance specifically related to equipment and processes. Following personnel will benefit from the course:

  • 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

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar




Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  1. Welcome, Introduction to the course and Speaker
  2. Regulatory requirements and expectations for Equipment Qualification
    1. Europe
    2. FDA
    3. Global harmonization and expectations
    4. Definitions
  3. Management of Documents, Documents required
    1. Validation Policy
    2. Validation Master Plan (VMP)
    3. Documents Equipment Qualification
    4. SOPs
    5. Responsibilities
    6. Validation Team
    7. Presumption for Qualification/Validation
  4. General Aspects of Qualification
    1. Qualification Phases, DQ, IQ, OQ, PQ
    2. Qualification of existing systems and equipment
    3. Requalification/Validation
  5. Performance Qualification
    1. SOPs
    2. Writing a qualification protocol, content
    3. Executing a qualification
    4. Tests, and data
    5. Documents
    6. Writing a qualification final report
  6. Questions
  1. Performance of a Process Validation
    1. SOPs
    2. Writing a Process validation protocol
  2. Guidelines on validating analytical methods
    1. Content and execution
    2. SOPs
    3. Writing the validation plan
    4. Methodology and performance
    5. Report writing for method validation
    6. Presumption for validation
  3. Support of Equipment Qualification and Process Validation
    1. Quality Management System
    2. Risk Analysis
    3. Calibration/Maintenance
    4. Change Control
    5. Auditing equipment qualification and process validation
  4. External Equipment Qualification and process Validation
    1. Contract Manufacturer
    2. Qualification/Validation by a supplier
  5. Review of FDA warning letters
  6. Case Study Exercise from current FDA Warning Letters
  7. Theoretical Case exercises
  8. Questions




Meet Your Instructor

Joy McElroy
Principle Consultant at Maynard Consulting Company

Upon earning a degree in Zoology at North Carolina State University, Joy 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 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 over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

In 2013 Joy 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.





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