Book Online Tickets for Best Practices for an Effective Cleaning, Palo Alto.  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 activitie

Best Practices for an Effective Cleaning Validation Program

 

  • One Dial-in One Attendee

    Last Date: 19-11-2019

    USD 229
  • Group-Max 10 Attendees-Location

    Last Date: 19-11-2019

    USD 599
  • 1x Person - Unlimited viewing for 6 Months

    Last Date: 19-11-2019

    USD 299
  • One CD-USB is for usage in one location only

    Last Date: 19-11-2019

    USD 399
  • Live + Recorded Version

    Last Date: 19-11-2019

    USD 399
  • Live + Training CD-USB

    Last Date: 19-11-2019

    USD 499

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About The Event

 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.

Why Should You Attend:

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.

Learning Objectives:

  • Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
  • Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
  • Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
  • Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies

Areas Covered in the Webinar:

  • 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 Will Benefit:

Individuals in management who interact with or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.

  • Senior quality managers
  • Quality professionals
  • Production supervisors
  • Validation engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Analytical method development personnel
  • Quality control and quality assurance personnel

Instructor Profile:

Joy McElroy

Joy McElroy
Principle Consultant, Maynard Consulting Company

Upon earning a degree in Zoology at North Carolina State University, Joy McElroy 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, Ms. McElroy 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, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy 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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

 

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