Company: Southeastern Home Oxygen Service Inc.
Date: 8/7/01
Product: Medical Oxygen
You failed to assure the adequacy of your firm’s current computer distribution tracking system. Review of 2 lots selected at random for comparison of production records with computerized tracking information revealed inconsistencies in the number of oxygen cylinders filled with those distributed.
FDA District: Atlanta District Office
Being Agile & Yet Compliant (Public)
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software
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2-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Dr Peter Rech, 2nd instructor (optional)
Next public offering: TBD
