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SPI USA, Inc., Bloomington, Indiana
Nov 6-7
- FDA Overview
- Device Risk Classification & the Approval Process
- Pre-market notification, 510(k)
- Pre-market Approval (PMA)
- Interacting with the FDA - From Regulations to Reality: A former FDA Reviewer's perspective
- Pre-Clinical Considerations for FDA Submissions
- Developing a successful strategy
- Standards and guidance
- Technical Report Writing
- Combination Products
- Regulatory Challenges
- Examples of drugs/biologics device combinations
- Case study: Drug Eluting Stents
- Quality Systems Regulations
- Purpose of Quality System
- The Quality System Regulations (QSRs)
- ISO 13485
- Combination Products: QSRs and CGMPs
- Chemistry, Manufacturing and Controls (CMC)
- Contents of the CMC Section
- Case Studies
- FDA Inspections
- The QSIT Process
- Preparation for an Inspection
- What Happens During the Inspection
- After the Inspec
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Organized by:
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SPI USA |
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Invited Speakers:
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Dr. Semih Oktay, former scientific reviewer at the U.S. Food and Drug Administration (FDA) and President and founder of CardioMed Device Consultants, LLC, will present this training seminar. Below is a synopsis of Dr. Oktay's credentials:
Worked for six years as an expert mechanical engineer and scientific reviewer for the FDA in the Office of Device Evaluation, Interventional Cardiology Devices Branch;
Served as primary reviewer in the product areas of coronary stents, peripheral stents, and balloon angioplasty catheters;
Represented the Agency at numerous panel advisory meetings, scientific symposia, policy conferences, and voluntary standards development organization meetings;
Provided consulting support and guidance in the areas of mechanical engineering, material science and medical device regulations to other FDA offices, U.S. governmental agencies, and international regulatory agencies;
Received both individual and group recognition awards from the Agency;
Experienced in interpreting and evaluating engineering data, developing and presenting reports of scientific review, and devising and modifying guidelines and protocols for the testing of medical devices;
He is also an Adjunct Faculty at the University of Maryland Baltimore County and his research interests are in coronary stents, balloon angioplasty and the effects of balloon angioplasty on coronary arteries.
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Deadline for Abstracts:
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Registration:
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Please consult our website (www.usaspi.com) or contact us at seminars@usaspi.com or (714) 924 0155
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E-mail:
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spiusa-washington@usaspi.com
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