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Development and Audit of Complaint Handling and MDR Processes
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Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control.
Recorded
Thursday,
May 6, 2010
10:00 AM PST | 01:00 PM EST,
Duration:60 Minutes
$295.00
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Equipment Validation, Tracking, Calibration, and Preventive Maintenance
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FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.
Recorded
Tuesday,
April 13, 2010
10:00 AM PST | 01:00 PM EST,
Duration:60 Minutes
$295.00
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ISO 13485: 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation
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Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success.
Recorded
Thursday,
March 25, 2010
10:00 AM PST | 01:00 PM EST,
Duration:60 Minutes
$295.00
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Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage
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Virtually all field inspections performed by FDA inspectors are done according to the QSIT.
Recorded
Thursday,
March 11, 2010
10:00 AM PST | 01:00 PM EST,
Duration:60 Minutes
$295.00
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Complaint Handling in Compliance with FDA and ISO Regulations
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Negative customer feedback about a product’s performance or safety is a strong indicator of whether a firm's manufacturing process is in control.
Recorded
,
$295.00
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Supplier and Internal Auditing
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The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company's personnel every day.
Recorded
,
$295.00
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Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
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Supplier qualification and assessment is required in both the QSR regulations and ISO standards.
Recorded
,
$295.00
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Personnel Training to Assure QSR and ISO Compliance
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This webinar will provide valuable assistance to all regulated companies, since personnel training is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
Recorded
,
$295.00
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FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
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This webinar is designed for those who perform, supervise, manage, audit, or oversee the creation, approval, control of labels and labelling
Recorded
,
$295.00
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How to Prepare for, Manage, and Follow-up to an FDA Inspection
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Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Recorded
,
$295.00
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A CAPA Primer - Elements of a CAPA Program and Uses of CAPA Data
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A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer.
Recorded
,
$295.00
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Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner
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A document control system is required for compliance with federal (FDA) and international (ISO) compliance.
Recorded
,
$295.00
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Management Controls Under QSR and ISO 13485
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The top management of a company is responsible for ensuring that all regulatory requirements are met.
Recorded
,
$295.00
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Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements
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There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.
Recorded
,
$295.00
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The 510(k) Submission: Requirements, Contents, and Options
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This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly.
Recorded
,
Duration:60 Minutes
$295.00
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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
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During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system.
Recorded
,
$295.00
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Development of a Supplier Quality Auditor Training Program
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To have an effective supplier audit program, your company must have an effective audit team.
Recorded
,
$295.00
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Regulatory Requirements for Process Validation and their Protocols for Medical Devices
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It is the goal of every manufacturing firm to maximize profit. This is often accomplished by process automation.
Recorded
,
$295.00
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Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
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The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF).
Recorded
,
$295.00
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The FDA Inspection Process: From SOP to 483
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Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Recorded
,
$295.00
|
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Design Control for Medical Device Professionals
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Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed.
Recorded
,
$295.00
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Best Practices in Supplier Management
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Supplier qualification and assessment is required in both the QSR regulations and ISO standards.
Recorded
,
$295.00
|
|
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Best Practices in Complaint Management
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Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control.
Recorded
,
$295.00
|
|
|
Understanding Corrective and Preventive Action, and Elements of a CAPA System
|
A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer.
Recorded
,
$295.00
|
|
|
FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
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Marketing wants to entice customers to buy your product instead of your competitor's! A common method is to make the labeling as eye-catching as possible.
Recorded
,
$295.00
|
|
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Development, Management, and Operation of an Effective Supplier and Internal Auditing System
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The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company’s personnel every day.
Recorded
,
$295.00
|
|
|
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner
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Document control can be a time- and paper-consuming process.
Recorded
,
$295.00
|
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...more
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