Cleaning & Cleaning Validation; an Overview

Instructor: Gamal Amer
Product ID: 701149
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2009

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

In this Cleaning validation training we will discuss preparing the cleaning validation protocol. Important aspects such as how to set acceptance criteria and how to measure cleanliness will then be reviewed.

A general overview of the cleaning process for equipment and facilities in the pharmaceutical industry. The regulatory requirements for a cleaning SOP will be defined by reviewing several examples of FDA 483 notices of adverse findings given to companies in the industry. Once the regulatory requirements are defined, we will outline the structure of a general cleaning SOP and provide examples of the information it should contain. Once we establish the contents of a cleaning SOP, we will discuss the issues associated with cleaning validation. We will discuss preparing the cleaning validation protocol. Important aspects such as how to set acceptance criteria and how to measure cleanliness will then be reviewed. Finally we will touch on issues such as analytical methods used in cleaning validation, manual versus automated cleaning, and revalidation.

Areas Covered in the seminar:

  • What are the cleaning regulatory requirements?
  • How to prepare a cleaning procedure?
  • When to clean and how long it would remain clean?
  • The contents of a cleaning validation protocol.
  • How to define cleaning acceptance criteria?
  • What are he various sampling methods?
  • Where to sample for residual during the validation effort?
  • What are the appropriate analytical methods.

Who will benefit:

This webinar will provide a broad overview of the cleaning and cleaning validation issues associated with the production of drug products.

  • End-users responsible for applications that need to be validated
  • R&D Personnel and scientists in the Drug and BioParmaceutical Industry
  • Technical Specialists in the drug and BioParmaceutical Industry
  • Manufacturing personnel in the Biotechnology Industry
  • Management personnel in the Drug and BioParmaceutical Industry
  • Personnel responsible for engineering in the Drug and BioParmaceutical Industry

Instructor Profile:

Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over 27 years of experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AICHE.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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