Events Tagged "online training"

Verification vs. Validation in Regulated Industrie

Attend this webinar to understand the differences and benefits of verification and validation.

Understanding Attribute Acceptance Sampling

This course provides the attendees with the tools needed to understand and implement acceptance sampling.

21 CFR Part 11 and Annex 11

This webinar details both regulations and provides details for implementing computerized systems.

First-in-Human and Subsequent Phase I studies

This Webinar goes over the scientific standards of the First-in-Human ("first-in-Man" / FIM) studies and other Phase I studies in the drug development process.

Changes in the EU Medical Device Directives

Changes in the EU Medical Device Directives; 2010 Modifications and the 2012 Recast of the MDD Directives

Auditing Computer Systems for FDA

This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation.

Excel Spreadsheet Validation to Eliminate 483s

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

The 510(k) Submission: Requirements and Options

This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly.

Master Verification & Validation Planning

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.

DHF, DMR, DHR, and the Technical File

This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR.

Post Market Surveillance for Medical Devices

Post market surveillance is changing, not only in the US, but also in the EU and Canada.

South Korea: Navigating the Clinical Trial

South Korea: Navigating the Clinical Trial and Regulatory Environment - Webinar By GlobalCompliancePanel

21 CFR Part 11 and Annex 11

21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanel

Conducting Successful Product Complaint Investigat

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel

Curtailing Microbial Excursions and Investigations

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems - Webinar By GlobalCompliancePanel

Proper Documentation of Risk Management

Proper Documentation of Risk Management for Compliance with ISO 14971 - Webinar By GlobalCompliancePanel

Device Changes and the 510(k)

Device Changes and the 510(k) - Webinar By GlobalCompliancePanel

Aspects to Consider for Clean Room Qualification

Aspects to Consider for Clean Room Qualification and Operation - Webinar By GlobalCompliancePanel

Efficient Computer System Validation

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel

Water System Biofilm Control and Microbial Monitor

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel

DHF, DMR, DHR, Technical File and Design Dossier

DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel

Validation of Analytical Methods for FDACompliance

Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel

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