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.

Register Now

Online using Credit card

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Media Partners



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Local Attractions

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.

The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.

City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity

We need below information to serve you better

Best Sellers
You Recently Viewed