Course "Regulatory Requirements and Principles for Cleaning Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

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:

By the end of this course attendees will:

  • 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

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

Attendance at 2 day seminar 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 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 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

Topic Background:

Cleaning validation programs for pharmaceutical firms are a regulatory expectation. The FDA, Health Canada, WHO and other regulatory agencies have published their expectations for a good cleaning validation program. There are also numerous textbooks, articles, and other helpful resources such as PDA’s Technical Report #29 (Revised 2012) “Points to Consider for Cleaning Validation”. The risk-based regulatory initiatives of the FDA focus new attention on the risks of cross-contamination. Some firms have highly potent molecules in their product mix. Advanced analytical methods are emerging with promises to detect molecules to the ppb levels. Understanding and implementing new technologies and principles pause challenges to a cleaning validation specialist to establish, manage and maintain a scientifically sound cleaning validation program.

This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

Course Outline:

DAY ONE (8:30 AM – 4:30 PM) DAY TWO (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • 9.00 am – 10.00 am: FDA Requirements and Industry Standard Practices
    1. Regulatory requirements, Guidelines, & Expectations
    2. Industry standards of cleaning
  • 10.00 am – 10.45 am: How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters
    1. CIP, COP, Manual Cleaning procedures – advantages and disadvantages
    2. Selection of Cleaning Agents for your equipment/product and adequate Parameters to provide best results
  • 10.45 am – 11.00 am: Break
  • 11.00 am – 12.00 pm: How to Develop a Cleaning Validation Policy/Program
    1. Why do you need a policy/program?
    2. Key elements of a policy/program
  • 12.00 pm – 1.00 pm: Lunch
  • 1.00 pm – 2.00 pm: How to Implement a Robust Cleaning Validation Plan
    1. The information gathering process
    2. Review of cleaning processes/procedures
    3. Analytical Method development and validation
    4. Use of the risk assessment concept to identify worst case products & equipment
    5. How to select challenge conditions and determine acceptance criteria and preparation of a product/equipment matrix
  • 2.00 pm – 2.45 pm: How to Implement a Robust Cleaning Validation Plan
    1. Health based and adulteration based limits calculations
    2. Use of visual criteria for determining if equipment is clean
    3. Concepts of clean hold time (CHT) and dirty hold time (DHT)
    4. Choice of sampling type (swab versus rinse), sampling protocols, use of digital photographs, & sampling rationale
    5. Documentation requirements – protocols, deviations and final reports
  • 2.45 pm – 3.00 pm: Break
  • 3.00 pm - 3.30 pm: Laboratory Issues in Cleaning
    1. Suitable sensitivity and specificity issues
    2. Recovery studies
    3. Training of samplers and sampling technique
  • 3.30 pm – 4.15 pm: Microbiological aspects of a cleaning validation program for manufacturing equipment:
    1. Cleaning after use versus sanitization before use
    2. Typical sanitization procedures
    3. Testing requirements
  • 4.15 pm – 4.30 pm: Questions/Answers/Comments
  • 8.30 am – 9.30 am: Keys to Cleaning Validation Maintenance – Remaining Compliant
    1. Change Control:
      1. Changes in Cleaning/Sanitization Agents, Cleaning Procedures, Manufacturing Equipment or Procedures and changes in Product Formulas
  • 9.30 am – 11.00 am: Keys to Cleaning Validation Maintenance – Remaining Compliant
      1. Proper evaluation and approval pre and post change implementation
      2. Documented evaluation and follow up.
  • 11.00 am – 11.15 am: Break
  • 11.15 am – 12.00 pm: Keys to Cleaning Validation Maintenance – Remaining
    1. Monitoring after equipment cleaning – Visual Inspection and Frequent Sampling/Testing
    2. Monitoring after area cleaning/sanitization procedures
  • 12.00 pm – 1.00 pm: Lunch
  • 1.00 pm – 2.00 pm: Issues for Specific Sub-Industries and Related Manufacturing Facilities
    1. Active Pharmaceutical Ingredient (API) Manufacturers
    2. Biotechnology Facilities
    3. Dietary Supplement Manufacturers
  • 2.00 pm – 2.45 pm: Current FDA concerns about validation of cleaning processes
    1. Cleaning validation deficiencies observed by the regulatory inspectors, as reported in Establishment Inspection Reports (EIRs), FDA 483 observations and Warning Letters
  • 2.45 pm – 3.00 pm: Break
  • 3.00 pm – 4.15 pm: The future of cleaning processes and cleaning validation
    1. Containment Concept, EMEA, and ISPE
    2. Use of Disposable Equipment
    3. New innovative equipment design facilitating easier cleaning
    4. New cleaning technology (e.g. sprayball design)
  • 4.15 pm – 4.30 pm: Questions/Answers/Comments

Meet Your Instructor

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.

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