GMP Training Systems

New Web Seminar

Cost Effective – Time Effective – In your Conference Room or Office

The How-to Guide to Effective
Cleaning and Cleaning Validation

Conducted by Gamal Amer, PhD

June 27, 2007

11:00 am - 12:00 pm EDT, 10:00 am - 11:00 CDT,
9:00 am - 10:00 am MDT, 8:00 am - 9:00 am PDT

Click here to check your local time against the times listed above
Note: Washington D.C. is representative of EDT (Eastern Daylight Time).

This seminar is a comprehensive 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, a discussion outlining the structure of a general cleaning SOP will ensue, including examples of the information it should contain.

Issues associated with cleaning validation will be identified and discussed as well as how to prepare an effective cleaning validation protocol.  Important aspects such as how to set acceptance criteria and how to measure cleanliness will be reviewed.  Issues such as analytical methods used in cleaning validation, manual versus automated cleaning, and revalidation will be addressed.

This seminar will be conducted on the telephone and is presented by Gamal Amer, PHD, an industry expert on this and other compliance related topics. 

In this unique audio seminar format, lasting just one hour, you will be able to follow along with a PowerPoint presentation, ask questions, and interact with Dr. Amer.   An outline of this seminar and Dr. Amer's qualifications can be found below.

The How-to Guide to Effective Cleaning and Cleaning Validation

Register now!

 Don’t like to order online?
Call us at 714-289-1233

All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the web location to download the handout materials.

We accept Visa, MasterCard, and American Express (AMEX).  All prices are in US dollars.

Note:  Our shopping cart is set to the highest security level.  Please make sure that the address corresponds to the credit card holder.  It may result in a declined order if the address doesn't match the address on file for the cardholder named on the credit card. 

Please enter your billing information EXACTLY as it appears on your credit card statement.

GMP070627A - Individual The How-to Guide to Effective Cleaning and Cleaning Validation Individual price - includes HANDOUT MATERIALS	$197.00
GMP070627B - Individual VALUE PACKAGE The How-to Guide to Effective Cleaning and Cleaning Validation Individual VALUE PACKAGE price includes HANDOUT MATERIALS and audio CD CD will be shipped three weeks after the seminar	$397.00
GMP070627C - Group (up to ten people) at your site/location The How-to Guide to Effective Cleaning and Cleaning Validation Group price – Gather your team in your conference room, includes HANDOUT MATERIALS	$397.00
GMP070627D - Group (up to ten people) BEST VALUE PACKAGE at your site/location The How-to Guide to Effective Cleaning and Cleaning Validation Group BEST VALUE PACKAGE price – Gather your team in your conference room, includes HANDOUT MATERIALS and audio CD. CD will be shipped three weeks after the seminar	$597.00 BEST VALUE Your entire team can attend, includes audio CD
Can't attend?  Get the CD and handout GMP070627E - CD and Handout materials The How-to Guide to Effective Cleaning and Cleaning Validation CD price includes HANDOUT MATERIALS and audio CD. CD will be shipped three weeks after the seminar	$397.00

Instructor

Gamal Amer, PhD

Dr. Gamal Amer is Senior Director of Regulatory Compliance and Validation at BE&K, Inc.  He is a Chemical Engineer by training and been involved in the Pharmaceutical and related industries for over 25 years. He has held positions of increased responsibility in R&D, Operations, Technical Services, Engineering, Quality Assurance, Compliance and Validation. His experience includes comprehensive process design in bulk pharmaceutical chemicals 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 lectured extensively in the US, Europe, Asia, and the Middle East and taught many courses on subjects such as controlled release technology, GMP trends, Process Analytical Technology, Cleaning Validation, Process Validation, Validation and Change Control, and implication of GMP compliance on process and facility design in the biotechnology industry.

Please forward this to your colleagues who may be interested.