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Risk-Based CAPA Systems
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CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and key source of regulatory problems.
Recorded
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$295.00
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Changes and the 510(k)
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The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Recorded
,
$295.00
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Best Selling Medical Device Webinars by John E. Lincoln
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CompliancePanel brings you a special offer on Medical Device Recorded Webinars.
Recorded
asd,
$795.00
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Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971 Requirements
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FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
Recorded
,
$295.00
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Avoid Warning Letters in View of the U.S. FDA’s Stated Goal to Increase Their Use
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FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
Recorded
,
$295.00
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The Design History File and the Technical File / Design Dossier
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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
,
$295.00
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Product Risk Management - ISO 14971:2007
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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
,
$295.00
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Risk-based Software Verification and Validation
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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
,
$295.00
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Root Cause Analysis – Starting at the Beginning
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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
,
$295.00
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Meet the New, Tougher FDA Expectations
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The last few years have seen the U.S. FDA come under increasing negative public scrutiny.
Recorded
,
$295.00
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Setting Up and Running a Tougher Supplier Audit Program
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The last few years have seen the U.S. FDA come under increasing negative public scrutiny.
Recorded
,
$295.00
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Drafting a Software V&V Documentation Package and Protocol
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The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
Recorded
,
$295.00
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Device Changes and the 510(k)
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The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Recorded
,
$295.00
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Process Verification / Validation Under HACCP, the cGMPS and ISO
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FDA Warning Letters and recent recalls in the media show major cGMP deficiencies in companies' validation activities.
Recorded
,
$295.00
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Product Risk Management Under ISO 14971:2007 and ICH Q9
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The U.S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk.
Recorded
,
$295.00
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Master Verification and Validation Planning Under the cGMPS and ISO 13485
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FDA Warning Letters and recent recalls in the media show major cGMP deficiencies in companies' validation activities.
Recorded
,
$295.00
|
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Change Control - The Achilles Heel of cGMP Compliance
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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
,
$295.00
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Webinar on CAPA Challenges
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CAPA, Corrective and Preventive Action, is a major element of cGMP compliance. Sadly, it is also a key source of regulatory problems.
Recorded
,
$295.00
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The DHF, Technical File and Design Dossier - Similarities, Differences and The Future
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This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDD's TF/DD. Differing purposes / goals.
Recorded
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$295.00
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Meeting Tougher U.S. FDA Expectations - Update
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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
,
$295.00
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Key Modules of an Effective CAPA SOP
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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
,
$295.00
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Design History File, and Technical File / Design Dossier - A Regulatory Overview
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This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD.
Recorded
,
$295.00
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...more
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