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Medical - Documentation & Proceedings

> Conference documentation, webinars & Proceedings

The 510(k) Submission: Requirements, Contents, and Options - WEBINAR

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures.

By : Compliance Online
Product Type : On Demand Webinar
Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees -WEBINAR

This Medical Device Directive training will discuss the recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct involvement.

By : Compliance Online
Product Type : On Demand Webinar
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.

By : Compliance Online
Product Type : On Demand Webinar
Clinical Evaluation Reports (CER's) Required for All Classes of Medical Devices in Europe

Understand what is the CER and how to prepare for and defend it and properly constructing a "bullet-proof Technical File and manage your documentation.

By : Compliance Online
Product Type : On Demand Webinar
Conducting Successful Product Complaint Investigations Webinar

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.

By : Compliance Online
Product Type : On Demand Webinar
Creating a Good Design History File for Audit Success

This webinar will cover the basics on how to maintain a good Design History File that will help a manufacturer during a regulatory compliance audit

By : Compliance Online
Product Type : On Demand Webinar
Eliminate the confusion - New 2012 Requirements for Clinical Laboratories to Meet GCP-Webinar

This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA (new requirements 2012) compliance.

By : Compliance Online
Product Type : On Demand Webinar
Strategic Software Validation Planning for Executives and Managers - Webinar

This training webinar will discuss how to approach Strategic software Validation planning so as to satisfy FDA by complying to new enforcement initiative by FDA.

By : Compliance Online
Product Type : On Demand Webinar
Lawful Pre-FDA Approval & Pre-FDA Clearance Communication Webinar

How to communicate prior to product launch and off-label discussion to avoid violations of the Anti-Kickback Statute and False Claims Act.

By : Compliance Online
Product Type : On Demand Webinar
The 6 Most Common Problems in FDA Software Validation & Verification

This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls.

By : Compliance Online
Product Type : On Demand Webinar
Auditing Systems for 21 CFR Part 11 Compliance - Webinar By ComplianceOnline

This webinar will present a methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory, along with templates and forms that attendees can modify for their own business.

By : Compliance Online
Product Type : On Demand Webinar
Verification and Validation (V&V) of Software in the Medical Devices

This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.

By : Compliance Online
Product Type : On Demand Webinar
How do I Keep FDA Happy with my Contract Manufacturer

This webinar will cover techniques and process that can help you assure reliability and consistent quality from your suppliers or contract manufacturers. You will learn how to monitor your supplier and ensure they meet FDA's quality requirements.

By : Compliance Online
Product Type : On Demand Webinar
Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues

This webinar covers FDA’s expectations from GMP facilities regarding raw material vendor selection,expectations from quality control and documentation processes, and training requirements, with case studies.

By : Compliance Online
Product Type : On Demand Webinar
Analytical Test Methods Validation: FDA, ICH and USP Requirements - Webinar

This training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation.

By : Compliance Online
Product Type : On Demand Webinar