Industries
Drugs / Biologics
Medical & Surgical
Food
SOX Compliance
IT Control and PCI
Customer Support
Call: 800-447-9407
Fax: 302-288-6884
support@globalcompliancepanel.com
News
...more news
Packs
Featured Speakers
Steven S Kuwahara
Founder & Principal, GXP Biotechnology, LLC
Javier Kuong
President, Management Advisory Services & Publications (MASP)
Gerry O'Dell
President, Gerry O’Dell Consulting
Webinar Search Results
Search Filter Used:
Topic: Not Specified Category: All Speaker: Jeff Kasoff Month: Any
Your search returned 30 results
Jeff Kasoff
FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
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.
Live  Thursday, September 16, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Jeff Kasoff
Development, Management, and Operation of an Effective Supplier and Internal Auditing System
The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company’s personnel every day.
Live  Thursday, September 30, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Jeff Kasoff
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner
Document control can be a time- and paper-consuming process.
Live  Tuesday, October 12, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
<<
Jeff Kasoff
Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements
There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.
Recorded View Anytime
$295.00
Jeff Kasoff
Management Controls Under QSR and ISO 13485
The top management of a company is responsible for ensuring that all regulatory requirements are met.
Recorded View Anytime
$295.00
Jeff Kasoff
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner
A document control system is required for compliance with federal (FDA) and international (ISO) compliance.
Recorded View Anytime
$295.00
Jeff Kasoff
A CAPA Primer - Elements of a CAPA Program and Uses of CAPA Data
A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer.
Recorded View Anytime
$295.00
Jeff Kasoff
How to Prepare for, Manage, and Follow-up to an FDA Inspection
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 View Anytime
$295.00
Jeff Kasoff
FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
This webinar is designed for those who perform, supervise, manage, audit, or oversee the creation, approval, control of labels and labelling
Recorded View Anytime
$295.00
Jeff Kasoff
Personnel Training to Assure QSR and ISO Compliance
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 View Anytime
$295.00
Jeff Kasoff
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
Supplier qualification and assessment is required in both the QSR regulations and ISO standards.
Recorded View Anytime
$295.00
Jeff Kasoff
Supplier and Internal Auditing
The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company's personnel every day.
Recorded View Anytime
$295.00
Jeff Kasoff
Complaint Handling in Compliance with FDA and ISO Regulations
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 View Anytime
$295.00
Jeff Kasoff
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner
Document control can be a time- and paper-consuming process.
Recorded View Anytime
$295.00
Jeff Kasoff
Development, Management, and Operation of an Effective Supplier and Internal Auditing System
The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company’s personnel every day.
Recorded View Anytime
$295.00
Jeff Kasoff
FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
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 View Anytime
$295.00
Jeff Kasoff
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 View Anytime
$295.00
Jeff Kasoff
Best Practices in Complaint Management
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 View Anytime
$295.00
Jeff Kasoff
Best Practices in Supplier Management
Supplier qualification and assessment is required in both the QSR regulations and ISO standards.
Recorded View Anytime
$295.00
Jeff Kasoff
Design Control for Medical Device Professionals
Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed.
Recorded View Anytime
$295.00
Jeff Kasoff
The FDA Inspection Process: From SOP to 483
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 View Anytime
$295.00
Jeff Kasoff
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
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 View Anytime
$295.00
Jeff Kasoff
Regulatory Requirements for Process Validation and their Protocols for Medical Devices
It is the goal of every manufacturing firm to maximize profit. This is often accomplished by process automation.
Recorded View Anytime
$295.00
Jeff Kasoff
Development of a Supplier Quality Auditor Training Program
To have an effective supplier audit program, your company must have an effective audit team.
Recorded View Anytime
$295.00
Jeff Kasoff
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system.
Recorded View Anytime
$295.00
Jeff Kasoff
The 510(k) Submission: Requirements, Contents, and Options
This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly.
Recorded View Anytime  Duration:60 Minutes
$295.00
Jeff Kasoff
Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage
Virtually all field inspections performed by FDA inspectors are done according to the QSIT.
Recorded View Anytime  Duration:60 Minutes
$295.00
Jeff Kasoff
ISO 13485: 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation
Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success.
Recorded View Anytime  Duration:60 Minutes
$295.00
Jeff Kasoff
Equipment Validation, Tracking, Calibration, and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.
Recorded View Anytime  Duration:60 Minutes
$295.00
Jeff Kasoff
Development and Audit of Complaint Handling and MDR Processes
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 View Anytime  Duration:60 Minutes
$295.00
<<