• Dan OLeary Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Dan OLeary
    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.

  • Dan OLeary Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Dan OLeary
    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.

  • Dan OLeary Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Dan OLeary
    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.

  • Dan OLeary Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤189.00
    by: Dan OLeary
    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.

  • Dan OLeary Recorded
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    Duration:75 Minutes
    Price: ¤189.00
    by: Dan OLeary
    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.

  • Dan OLeary Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤189.00
    by: Dan OLeary
    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?

  • Dan OLeary Recorded
    View Anytime
    Duration:75 Minutes
    Price: ¤189.00
    by: Dan OLeary
    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".

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