Equipment Qualification and Process Validation

Date: Thursday, 30 January 2020 | Time: 10:00 AM PST, 01:00 PM EST | Duration: 90 Minutes
This equipment qualification and validation webinar will help you to understand the various processes of equipment qualifications (IQ, OQ & PQ) and process validation steps (when, what and how to test) in a manufacturing process. It will also highlight all the requirements of FDA cGMP regulations that all equipment to be qualified and all manufacturing processes be validated if problems are encountered changes have to make and periodically as necessary.
Equipment Qualification and Process Validation
Instructor: Joy L McElroy
Product ID: 505620
Objectives of the Presentation
  • General FDA GMP information re qualification and validation
  • Equipment Qualification
    • IQ
    • OQ
    • PQ
  • Computer System Qualification and Part 11
  • Manufacturing Process Validation
    • Specifications
    • When to test
    • What to test
    • How much to test
Why Should you Attend
Process validation involves proof that each step of a manufacturing process does what it is supposed to do. The degree of proof required will be discussed. When sampling after a step will not provide accurate information (e.g. some blend uniformity test results) will be considered.

These equipment qualifications and process validations must be repeated if changes are made or if problems are encountered, and periodically as necessary. How often to revalidate will be discussed.

Equipment qualification includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). All three will be discussed and examples from both manufacturing and laboratory equipment will be provided. Retrospective qualification of previously unqualified equipment already in place will be considered. Qualification of computer systems will also be presented.

Attend this webinar to understand each of the above process for equipment qualification & steps for process validation of FDA cGMP regulations.

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
Topic Background
Lack of qualification or validation is a common FDA inspectional observation and FDA Warning Letter violation. Those involved in equipment qualification, including information technology (IT) and process validation will benefit from a review of the relevant FDA rules, written and unwritten.

FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes validated.
$229
Live Session for one participant
If you sign up and can't make it Don't Worry! We'll send you a link
to view the deck and recording the day after the webinar..
Book this course
Pay Now
Pay Later
  $299.00 Recorded Session
Get life time access for one participant with download option!
  $379.00 Training CD
Free shipment within 4 Working Days, from the date of webinar completion. Get life time access for unlimited participants.
  $429.00 Training USB Flash Drive
Free shipment within 4 Working Days, from the date of webinar completion. Get life time access for unlimited participants.
  $799.00 Corporate Live Session
Unlimited Participants
  $329.00 Super combo offer
Live Session for one Participant + Recorded Session
  $399.00 Super combo offer
Live Session for one Participant + Training CD
  $449.00 Super combo offer
Live Session for one Participant + Training USB Flash Drive
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest.

Her knowledge, experience, and strong work ethic 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.

In 2013 Joy started, Maynard Consulting Company, which provided engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States.

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, Canada, and the world.

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.
View More