Speaker Profile
Dan OLeary
President, Ombu Enterprises
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Statistical Concepts of Process Validation
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".
Speaker: Dan OLeary | View Anytime | Duration: 75 Minutes | Price: ¤189.00 | View Details
Device Corrections and Removals
When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View Details
Regulatory Requirements for Medical Device Calibration Programs
Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement.
Speaker: Dan OLeary | View Anytime | Duration: 75 Minutes | Price: ¤189.00 | View Details
Acceptance Sampling by Variables
Many companies use attribute sampling plans at incoming, in-process, and final inspection. The common approach uses ANSI/ASQ Z1.4. There is an alternate, however, that may reduce cost. Sampling plans based on ANSI/ASQ Z1.9 can reduce cost by requiring smaller sample sizes.
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View Details
Statistical Concepts of Process Validation
Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation. The presentation examines elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485:2016.
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Understanding Attribute Acceptance Sampling Plans Including the Z1.4 and c=0 Plans
Attribute acceptance sampling is a common tool for medical device manufacturers. Unfortunately, many people don't understand the underlying concepts or the basis for decision making. This presentation explains the underlying ideas of attribute sampling plans and how to use the two most common published plans, Z1.4 and c=0. In addition, the presentation describes the major differences between the approaches. Attribute sampling plans are characterized by the operating characteristic curve (OC curve) which provides the basis for sampling risk. The presentation explains how to read the OC and use it to help select sampling plans.
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Excel Workbooks and FDA Device Regulations
This presentation helps participants understand the FDA's device regulations for Excel workbooks. These workbooks could automate process, influence product decisions, support regulatory submissions, or create electronic records. FDA regulations cover both the use of workbooks and the creation of electronic records; device manufacturers must understand these regulations and their application.
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Statistical Concepts of Process Validation
Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation. The presentation examines elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485:2016.
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: ¤390.00 | View Details
Understanding Attribute Acceptance Sampling Plans Including the Z1.4 and c=0 Plans
Attribute acceptance sampling is a common tool for medical device manufacturers. Unfortunately, many people don't understand the underlying concepts or the basis for decision making. This presentation explains the underlying ideas of attribute sampling plans and how to use the two most common published plans, Z1.4 and c=0. In addition, the presentation describes the major differences between the approaches. Attribute sampling plans are characterized by the operating characteristic curve (OC curve) which provides the basis for sampling risk. The presentation explains how to read the OC and use it to help select sampling plans.
Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: ¤390.00 | View Details