2-Day Virtual Seminar

The Life Cycle Approach to Cleaning Validation

BY: Joy McElroy, Principle Consultant at Maynard Consulting Company

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

August 25-26, 2020
(8:00 AM to 4:00 PM EDT)
Virtual Seminar
  • Course Description
  • Agenda
  • Speaker
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This seminar will cover the aspects, procedures, rules and limits regarding cleaning validation in the pharmaceutical industry. Why FDA requires a cleaning validation program and which equipment must be tested will be discussed. How to plan a cleaning validation program, select which substances to focus on, write procedures for cleaning equipment and prepare cleaning validation protocols will be covered. How to calculate maximum allowable carryover (MCA), Surface Acceptance Limits (SAL), Therapeutic dose, Surface Contamination level, Swab residue, No Observed effect level (NOEL), and Acceptable Daily intake (ADI) will be explained. Sampling techniques and their validation, as well as analytical methods and their validation will be covered. How to write a cleaning validation report and how to document decision regarding new products will be reviewed. Recent Warning Letters and Inspection Observations from FDA will be used to discuss what not to do.

Learning Objectives:
  • Understand why cleaning validation is required
  • Know how to plan a cleaning validation program
  • Know how to write cleaning validation protocols
  • Know how to calculate limits for cleaning validation
  • Understand selection of analytes
  • Understand validation of analytical methods
  • Know how to write a cleaning validation report
  • Know what not to do
Who will Benefit:
  • Quality Assurance
  • Quality Control
  • Manufacturing Supervisors
  • Regulatory Affairs
Day 01(8:00 AM - 4:00 PM EDT)
  • 9:00 AM - 10:00 AM
    • Seminar objectives review, expectations and scope.
    • Why is cleaning validation required?
    • Which equipment must be tested?
  • 10:00 AM - 11:00 AM
    • Written procedures for cleaning equipment
    • Selection of most difficult to remove substances
    • Overall cleaning validation plan
    • Protocols
  • 11:00 AM - 12:00 PM
    • Limits for cleaning validation
    • Questions
  • 12:00 PM - 01:00 PM Lunch
  • 01:00 PM - 02:00 PM
    • Sampling techniques
    • Validation of analyte recovery
  • 02:00 PM - 03:00 PM
    • Analytical methods
    • Limits of Quantitation (LOQ)
    • Out of Specification (OOS) results
  • 03:00 PM - 04:30 PM: Questions and comments
Day 02(8:00 AM - 4:00 PM EDT)
  • 9:00 AM - 10:00 AM
    • Review of information and questions from Day 1
  • 10:00 AM - 11:00 AM
    • Writing a cleaning validation report
    • Adding a new substance to the cleaning validation program
    • Decision memos
  • 11:00 AM - 12:00 PM
    • 483s and Warning Letters re cleaning validation
  • 12:00 PM - 01:00 PM Lunch
  • 01:00 PM - 04:00 PM
    • More what not to do
    • More questions and comments
Joy McElroy
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.

Register Now

Online using Credit card

$1,699.00

(One Dial-in One Attendee)

August 25-26, 2020, Virtual Seminar
(Registrations till August 10, 2020 - $1699)
(Registrations after August 10, 2020 - $1999)

$8,665.00

Group-Max. 10 Attendees

August 25-26, 2020, Virtual Seminar
(Registrations till August 10, 2020 - $8665)
(Registrations after August 10, 2020 - $10195)


For discounts on multiple registrations, contact customer care at +1-888-771-6965.

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