3-Hour Virtual Seminar on Effective Cleaning Validation Procedures – Best Practices

Recorded Webinar | Joy McElroy | From: Nov 17, 2020 - To: Dec 31, 2020

Training Options & Pricing

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Recording
   $329  
DVD
   $349  
Recording + DVD
   $499  
Transcript (Pdf)
   $329  
Recording & Transcript (Pdf)
   $489  
DVD & Transcript (Pdf)
   $499  


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This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs, and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.

This course will provide practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable, and informed decision making and activity planning. The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a “Cleaning Validation Master Plan” and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.

Areas Covered in the Session:-

  • FDA Requirements and Industry Standard Practices
  • How to Develop/Review Your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters
  • How to Develop a Cleaning Validation Policy/Program
  • How to Implement a Robust Cleaning Validation Plan
  • Laboratory Issues in Cleaning
  • Microbiological Aspects of a Cleaning Validation Program for Manufacturing Equipment
  • Keys to Cleaning Validation Maintenance – Remaining Compliant
  • Current FDA Concerns About Validation of Cleaning Processes

Who Should Attend:-

  • Quality Departments
  • Engineering Departments
  • Production Departments
  • Manufacturing Departments
  • Validation Departments
  • Operations Departments
  • Process Owners
  • Quality Auditors

Joy McElroy

 

Joy McElroy Upon earning a degree in Zoology at North Carolina State University, She 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. 

Upon earning a degree in Zoology at North Carolina State University, She 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.