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
Anthony G. Tarantino
, Adjunct professor of finance, Santa Clara University
Mark Roberts
Founder, Roberts Consulting & Engineering
Steven Walfish
President, Statistical Outsourcing Services
Webinar Search Results
Search Filter Used:
Topic: Not Specified Category: All Speaker: John E Lincoln Month: Any
Your search returned 23 results
John E Lincoln
Design History File, and Technical File / Design Dossier - A Regulatory Overview
This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD.
Live  Wednesday, September 22, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
<<
John E Lincoln
Changes and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Recorded View Anytime
$295.00
John E Lincoln
Risk-Based CAPA Systems
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and key source of regulatory problems.
Recorded View Anytime
$295.00
John E Lincoln
Design History File, and Technical File / Design Dossier - A Regulatory Overview
This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD.
Recorded View Anytime
$295.00
John E Lincoln
Key Modules of an Effective CAPA SOP
This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs, especially CAPA.
Recorded View Anytime
$295.00
John E Lincoln
Meeting Tougher U.S. FDA Expectations - Update
This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs.
Recorded View Anytime
$295.00
John E Lincoln
The DHF, Technical File and Design Dossier - Similarities, Differences and The Future
This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDD's TF/DD. Differing purposes / goals.
Recorded View Anytime
$295.00
John E Lincoln
Webinar on CAPA Challenges
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance. Sadly, it is also a key source of regulatory problems.
Recorded View Anytime
$295.00
John E Lincoln
Change Control - The Achilles Heel of cGMP Compliance
The last few years have seen an increase in product recalls. For this and other reasons, the U.S. FDA come under increasing negative public scrutiny.
Recorded View Anytime
$295.00
John E Lincoln
Master Verification and Validation Planning Under the cGMPS and ISO 13485
FDA Warning Letters and recent recalls in the media show major cGMP deficiencies in companies' validation activities.
Recorded View Anytime
$295.00
John E Lincoln
Product Risk Management Under ISO 14971:2007 and ICH Q9
The U.S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk.
Recorded View Anytime
$295.00
John E Lincoln
Process Verification / Validation Under HACCP, the cGMPS and ISO
FDA Warning Letters and recent recalls in the media show major cGMP deficiencies in companies' validation activities.
Recorded View Anytime
$295.00
John E Lincoln
Device Changes and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Recorded View Anytime
$295.00
John E Lincoln
Drafting a Software V&V Documentation Package and Protocol
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
Recorded View Anytime
$295.00
John E Lincoln
Setting Up and Running a Tougher Supplier Audit Program
The last few years have seen the U.S. FDA come under increasing negative public scrutiny.
Recorded View Anytime
$295.00
John E Lincoln
Meet the New, Tougher FDA Expectations
The last few years have seen the U.S. FDA come under increasing negative public scrutiny.
Recorded View Anytime
$295.00
John E Lincoln
Root Cause Analysis – Starting at the Beginning
Root Cause Analysis (RCE) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Recorded View Anytime
$295.00
John E Lincoln
Risk-based Software Verification and Validation
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Recorded View Anytime
$295.00
John E Lincoln
Product Risk Management - ISO 14971:2007
This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.
Recorded View Anytime
$295.00
John E Lincoln
The Design History File and the Technical File / Design Dossier
The DHF is a key element of Design Control under the GMPs, and is a major subject for review during a U.S FDA compliance audit.
Recorded View Anytime
$295.00
John E Lincoln
Avoid Warning Letters in View of the U.S. FDA’s Stated Goal to Increase Their Use
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
Recorded View Anytime
$295.00
John E Lincoln
Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971 Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
Recorded View Anytime
$295.00
John E Lincoln
Best Selling Medical Device Webinars by John E. Lincoln
CompliancePanel brings you a special offer on Medical Device Recorded Webinars.
Recorded View Anytime
$795.00
<<