Cost Effective and Convenient - in your office or conference room
GMP and Validation Forum
Top industry experts reveal insights into what really matters in GMP and Validation
Conducted by Gamal Amer, Ph.D. and David Markovitz
September 28, 2016
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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)
Combined, Gamal Amer, PhD and David Markovitz have over six decades of hands-on experience in GMP compliance and managing validation processes. In this webinar, they will share what they have learned in making GMP compliance and validation part of the fabric of an organization.
Here are just some the topics they will address.
- Proven strategies to ensure that you are in GMP compliance
- Why compliance and validation are critical to your success
- Validation requirements in the FDA regulated industries
- How to measure the cost of non-compliance
- How to get senior level management to embrace and own GMP compliance
- How to use FDA guidance documents as important resources
- What mistakes to avoid when dealing with FDA inspectors
We encourage attendees to submit questions in advance of the webinar.
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.
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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.
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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.
David Markovitz is the President of GMP Training Systems, Inc., an education, training, and consulting firm whose mission is to help organizations improve their productivity, quality, and long-term profitability by implementing strategies focused on innovation, continual improvement and optimization of work systems and processes throughout all levels in an organization. With a corporate background of management positions in Manufacturing Operations for four different companies over two decades, David knows first hand how to overcome the challenges in implementing quality systems.
David honed his expertise on Quality Systems when he had the rare privilege of assisting Dr. W. Edwards Deming, the 20th century’s leading quality guru, in several of his famed Four-Day Seminars. David created and led the Deming Roundtable, an intensive year-long cooperative effort involving eight different organizations working to implement Deming’s teachings and develop a Quality Systems approach.
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