Cost Effective and Convenient - in your office or conference room
Developing and Maintaining a Robust Change Control System
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
April 19, 2017
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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.
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(Note: Washington DC and New York are in the EDT)
Managing changes in pharmaceuticals manufacturing through implementing a change control procedure is a regulatory requirement. Change Control is used by drug producers as a risk mitigation tool and to maintain the operations in a validated state of control.
This seminar will guide you through a process of developing and maintaining a robust change control system.
1. Why the Need for Change Control
- What is change control
- The regulatory imperatives
- Mitigating risk to quality
- Maintaining GMP compliance
- Maintaining the validated state
- The types of change and their potential impact
2. Understand the components of a Change Control System
- Outline of a robust change control procedure
- The change request form
- Impact assessment of the change
- Planning for Implementation
3. Applying Change Control
- Implementation of the change and the requirements to maintain compliance
- The importance of post change monitoring
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.
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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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