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Law & Regulation - 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
FAIR LABOR STANDARDS ACT (FLSA) – What Supervisors Need to Know- WEBNINAR

In this FLSA training, learn the do’s and don’ts of Fair Labor Standards Act (from exempt to nonexempt, to independent contractor versus employee-employer relationship) and start avoiding the landmines.

By : Compliance Online
Product Type : On Demand Webinar
Fundamentals of FDA’s Clinical Trial Audits – A Must- Know for Audit preparation

This Clinical Trial Audits webinar will provide help both CRAs and sites utilize quality improvement methods and effectively prepare for upcoming GCP audits.

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
21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection

This 21 CFR Part 11, FDA Inspection training/Webinar will discuss how to prepare and host an FDA inspection with 21 CFR part 11 is in the scope of the inspection.

By : Compliance Online
Product Type : On Demand Webinar
Complying with FLSA – How to Determine Exempt Status & Calculate Overtime Correctly

This webinar on employee overtime calculation will help you understand what is “time worked”, exempt versus non-exempt status and how to calculate your employees' overtime correctly so to avoid these costly suits.

By : Compliance Online
Product Type : On Demand Webinar
Food Safety Traceability Systems: Identifying, Locating and Knowing the Condition of Food in the Supply Chain

This 90-minute webinar on food safety traceability systems will explore new and cost-effective technologies that enable you to identify, locate and know the condition of food at all stages of shipment and handling.

By : Compliance Online
Product Type : On Demand Webinar
Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance

This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation.

By : Compliance Online
Product Type : On Demand Webinar
Equipment Calibration in FDA QSR – Regulations and Warning Letters

This webinar explains concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001.

By : Compliance Online
Product Type : On Demand Webinar
Acceptance Activities in FDA QSR – Regulations and Warning Letters

This webinar will explain the FDA QSR requirements for acceptance activities related to medical device manufacturing.

By : Compliance Online
Product Type : On Demand Webinar
Pharmaceutical Water System Use & Monitoring

This webinar on pharmaceutical water systems will explain practical best practices for outlet use and sampling to reflect the true water quality and how to most effectively use the resulting data to improve manufacturing’s water use practices.

By : Compliance Online
Product Type : On Demand Webinar
OSHA Inspections – Avoiding the 10 Most Common Mistakes

This webinar will cover aspects of an OSHA inspection from how establishments are targeted, how to limit the scope of an inspection or investigation, how not to self-incriminate, and when and how to appeal.

By : Compliance Online
Product Type : On Demand Webinar
Application of CAPA in (Device) Sterilization – For the Non-Expert

This webinar will review the typical non-conformances experienced in the (Medical Device) sterilization process and the course of action that should be taken by the manufacturer or contract sterilizer.

By : Compliance Online
Product Type : On Demand Webinar