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
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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.
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.
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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.
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