Cost Effective and Convenient - in your office or conference room

Conducting a Gap Analysis of Your Process Validation Program

Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.

October 2, 2015
Scroll down to register

11:00 am EDT, 10:00 am CDT,
9:00 am MDT, 8:00 am PDT
The seminar will run for one hour.

Click here to check your time
(Note: Washington DC and New York are in the EDT)

Plan for a successful Gap Analysis

  • Define what is needed to complete the analysis
  • Develop the tools to conduct the Gap Analysis
  • Train your personnel to conduct the Gap Analysis
  • Define the scope of your Gap Analysis

Determine the Gap in your Process Validation Program

  • Define the ideal where you would like to be
  • Determine where you are
  • Define the Gap and what needs to be accomplished to bridge the Gap
  • Communicate with stakeholders

Develop an implementation plan to Bridge the Gap

  • Documents to help define the plan
  • Use of a phased approach based on Risk
  • Schedule and cost of the various activities
  • Prepare a report and get approval

This seminar will be conducted using GotoMeeting.com and is presented by Gamal Amer, Ph.D., an industry expert on this and other compliance related topics.

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

The log-in information and a handout presentation file (to use as a backup) will be sent to you via email the day before the seminar.

 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 presentation handout materials the day before the seminar.

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.

Individual participant
GMP150508A - Includes participation and all handout materials
Gap Analysis of
Process Validation
$247.00 Add to Cart

Value Package - Individual participant PLUS MP3
GMP150508B - Includes participation, an audio MP3 file, and all handout materials
Gap Analysis of Process Validation

$447.00 Add to Cart
Group participation - Gather your department (up to ten people) in a conference room or in their offices
GMP150508C - Includes participation for up to ten people at the same site and all handout materials
Gap Analysis of Process Validation
$447.00 Add to Cart
Best Value Package - Group participation PLUS MP3 - Gather your department (up to ten people) in a conference room or in their offices
GMP150508D Includes participation for up to ten people at the same site, and audio MP3 file, and all handout materials
Gap Analysis of Process Validation
$647.00 Add to Cart
Get the MP3 file and handout
GMP150508E - MP3 audio file and Handout materials
Gap Analysis of Process Validation
$447.00 Add to Cart

Instructor

Gamal Amer, Ph.D.
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 two decades 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.

Please forward this to your colleagues who may be interested.