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Webinar Search Results
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Your search returned 13 results
Dan OLeary
Understanding Acceptance Activities for Medical Devices
Acceptance activities are common in device manufacturing, but seem to cause problems for some manufacturers. These problems range from simple instances of lack of procedures or acceptance criteria to misapplication of statistical methods.
Live  Tuesday, September 14, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:75 Minutes
$245.00
Dan OLeary
Outsourced processes and ISO 9001:2008
In 2008, a new edition of ISO 9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements.
Live  Tuesday, September 28, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:75 Minutes
$245.00
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Dan OLeary
Outsourced processes and ISO 9001:2008
In 2008, a new edition of ISO 9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements.
Recorded View Anytime
$295.00
Dan OLeary
Understanding Acceptance Activities for Medical Devices
Acceptance activities are common in device manufacturing, but seem to cause problems for some manufacturers. These problems range from simple instances of lack of procedures or acceptance criteria to misapplication of statistical methods.
Recorded View Anytime
$295.00
Dan OLeary
Regulatory Requirements for Medical Device Calibration Programs
Calibration is an essential component of every Quality Management System (QMS).
Recorded View Anytime
$295.00
Dan OLeary
Excel Spreadsheets and FDA Device Regulations
This seminar helps you understand the FDA device regulations related to Excel spreadsheets.
Recorded View Anytime
$345.00
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".
Recorded View Anytime
$295.00
Dan OLeary
Process Validation for Medical Devices
This webinar explains the fundamental requirements for process validation in both FDA QSR and ISO 13485. You will learn when a process should be validated, the basic components of a process validation (IQ, OQ, and PQ) and how to write protocols and reports.
Recorded View Anytime
$295.00
Dan OLeary
Implementing QSR and ISO 13485 requirements for CAPA and Corrections
The difference between corrective action and preventive action is often confusing. There are, however, formal definitions that show the difference between them.
Recorded View Anytime
$295.00
Dan OLeary
Managing the Medical Device Supply Chain
In this seminar, you will learn both the requirements for managing suppliers and the reasons for these requirements.
Recorded View Anytime
$295.00
Dan OLeary
A Unified Approach to Complaints, Servicing, and FDA Reporting
This course provides the attendees with the information to implement an effective system for managing and reporting adverse events.
Recorded View Anytime
$295.00
Dan OLeary
Risk Management for Medical Devices - ISO 14971
This course provides the attendees with an overview of ISO 14971:2007 and implementation tips for an effective system for managing risk.
Recorded View Anytime
$295.00
Dan OLeary
Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
This course provides the attendees with the tools needed to understand and implement acceptance sampling.
Recorded View Anytime
$295.00
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