Best practices for effective Cleaning Validation Webinar
This webinar provides practical guidance on cleaning validation guidelines for regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning.
This webinar 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 FDA training will also be included in the webinar.
Why Should You Attend
This webinar 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 webinar particularly useful. This includes Analytical Method Development, Quality Control, and Quality Assurance personnel.
Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this webinar. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.
Areas Covered In This 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
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 due to regulatory compliance requirements
Who Will Benefit
Senior Quality Managers
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 of 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.