home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Meetings and Conferences  
 

The Life Cycle Approach to Cleaning Validation

 
  August 11, 2020  
     
 
Compliance online, Online Event
August 25-26, 2020


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

Areas Covered:

  • Cleaning Validation Plans
  • Protocols
  • Limits
  • Analyte Selection
  • Analytical Methods
  • Cleaning Validation Reports

Who will benefit:

  • Quality Assurance
  • Quality Control
  • Manufacturing Supervisors
  • Regulatory Affairs
 
 
Organized by: ComplianceOnline
Invited Speakers:
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.

 
Deadline for Abstracts: 2020-08-10
 
Registration: https://www.complianceonline.com/regulatory-requirements-and-principles-for-cleaning-validation-seminar-training-80353SEM-prdsm?channel=hum-molgen
E-mail: referral@complianceonline.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.