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Implementing FDA's Updated Guidance on Quality Metrics
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
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This one-hour seminar was conducted using GotoMeeting and is presented by Gamal Amer, PhD, a leading industry expert on GMP and Validation.
You receive the GotoMeeting MP4 file which includes the slides and audio from this seminar. You can save this file to your system. Use Windows Media Player or equivalent player to open and run this file. View in your office or gather your team in a conference room.
This seminar addresses FDA’s proposed guidance on Quality Metrics updated in November 2016. This guidance represents FDA’s current thinking on using quality data provided by the manufacturer to calculate quality metrics and is still in its formative stage. The FDA suggests that the calculated quality metrics will be used to determine the level of compliance risk associated with a specific manufacturer’s operation and defines an inspectional approach and schedule for that facility. Additionally, the agency will use the data collected and the calculated Quality Metrics in an effort to circumvent potential drug shortages, which may occur due to quality issues for the manufacturer.
This seminar will address:
- The legal basis for the FDA requesting data prior or in lieu of an inspection
- Establishments covered and those not covered by the guidance and who reports
- How the FDA intends to apply the approach outlined in the guidance
- What are the Quality Metrics to be calculated by the FDA
- What Quality data will be requested by the FDA to calculate the metrics
- Dealing with foreign establishment not governed by FDA requirements
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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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Implementing FDA's Guidance on Quality Metrics
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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