ComplianceOnline

This seminar will cover the aspects, procedures, rules and limits regarding cleaning validation in the pharmaceutical industry. Why FDA requires a cleaning validation program and which equipment must be tested will be discussed. How to plan a cleaning validation program, select which substances to focus on, write procedures for cleaning equipment and prepare cleaning validation protocols will be covered. How to calculate maximum allowable carryover (MCA), Surface Acceptance Limits (SAL), Therapeutic dose, Surface Contamination level, Swab residue, No Observed effect level (NOEL), and Acceptable Daily intake (ADI) will be explained. Sampling techniques and their validation, as well as analytical methods and their validation will be covered. How to write a cleaning validation report and how to document decision regarding new products will be reviewed. Recent Warning Letters and Inspection Observations from FDA will be used to discuss what not to do.

Learning Objectives:

  • Understand why cleaning validation is required
  • Know how to plan a cleaning validation program
  • Know how to write cleaning validation protocols
  • Know how to calculate limits for cleaning validation
  • Understand selection of analytes
  • Understand validation of analytical methods
  • Know how to write a cleaning validation report
  • Know what not to do

Areas Covered:

  • Cleaning Validation Plans
  • Protocols
  • Limits
  • Analyte Selection
  • Analytical Methods
  • Cleaning Validation Reports

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification

Who will benefit:

  • Quality Assurance
  • Quality Control
  • Manufacturing Supervisors
  • Regulatory Affairs
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:00 AM - 4:00 PM EDT)
  • 9:00 AM - 10:00 AM
    • Seminar objectives review, expectations and scope.
    • Why is cleaning validation required?
    • Which equipment must be tested?
  • 10:00 AM - 11:00 AM
    • Written procedures for cleaning equipment
    • Selection of most difficult to remove substances
    • Overall cleaning validation plan
    • Protocols
  • 11:00 AM - 12:00 PM
    • Limits for cleaning validation
    • Questions
  • 12:00 PM - 01:00 PM Lunch
  • 01:00 PM - 02:00 PM
    • Sampling techniques
    • Validation of analyte recovery
  • 02:00 PM - 03:00 PM
    • Analytical methods
    • Limits of Quantitation (LOQ)
    • Out of Specification (OOS) results
  • 03:00 PM - 04:30 PM: Questions and comments
Day 02(8:00 AM - 4:00 PM EDT)
  • 9:00 AM - 10:00 AM
    • Review of information and questions from Day 1
  • 10:00 AM - 11:00 AM
    • Writing a cleaning validation report
    • Adding a new substance to the cleaning validation program
    • Decision memos
  • 11:00 AM - 12:00 PM
    • 483s and Warning Letters re cleaning validation
  • 12:00 PM - 01:00 PM Lunch
  • 01:00 PM - 04:00 PM
    • More what not to do
    • More questions and comments
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Joy McElroy

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 by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,699.00

(One Dial-in One Attendee)

August 25-26, 2020, Virtual Seminar
(Registrations till July 10, 2020 - $1699)
(Registrations after July 10, 2020 - $1999)

$8,665.00

Group-Max. 10 Attendees

August 25-26, 2020, Virtual Seminar
(Registrations till July 10, 2020 - $8665)
(Registrations after July 10, 2020 - $10195)



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 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

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Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Note: In view of Coronavirus situation and travel advisory issued, ComplianceOnline will waive off all cancellation charges for the registrations till June 30, 2020.

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 @ customercare@complianceonline.com

Payment:

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 for In-person Seminars:

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 $300 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 ($300) 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.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) 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. Some topics and speakers may be subject to change without notice.
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