The Life Cycle Approach to Cleaning Validation: 2-Day In-person Seminar

By: Loren Gelber, Regulatory Compliance Consultant (Ex-FDA Official)
Location :- San Diego, CA | Thursday, November 21, 2019 | Friday, November 22, 2019

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Course Description:

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 the limits for both toxic and nontoxic impurities will be explained. Sampling techniques and their validation, as well as analytical methods and their validation will be covered. What to do about extraneous peaks and other out-of-specification results will be discussed. 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

Who will Benefit:

  • Quality Assurance
  • Quality Control
  • Manufacturing Supervisors
  • Regulatory Affairs

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 8:30 AM – 9:00 AM: Registration Meet & Greet.
  • 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 Two (8:30 AM – 4:30 PM)
  • 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

Meet Your Instructor

Loren Gelber
Loren Gelber
Regulatory Compliance Consultant (Ex-FDA Official)

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She then transitioned to industry, working for four different pharmaceutical companies. She has authored, reviewed and approved many cleaning validation documents, and has been the lead of company’s inspection team for many FDA inspections. For the last 14 years she has been a regulatory compliance consultant, both for consulting companies and independently.

Location :
San Diego, CA
(Venue to be announced shortly)
November 21-22, 2019
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Seminar One Registration

November 21-22, 2019, San Diego, CA
(For Registrations till September 20, 2019 - $1699)
(For Registrations after September 20, 2019 - $1899)

Your registration fee includes the workshop, all course materials and lunch.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

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Payment is required before 2 days of 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 $300 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 seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars 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 GRC Seminars cancels the seminar, GRC Seminars 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.

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