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Healthcare & Pharma Law - 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
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
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
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
FDA's Rules for Financial Disclosure in Clinical Trials Clarified: New Guidance, Practical Application

This webinar will help you understand the current FDA requirements regarding financial disclosure in clinical trials. It will discuss differences from the older requirements, and tips to assure compliance all start of clinical trials till the submission of data in a marketing approval application.

By : Compliance Online
Product Type : On Demand Webinar
OSHA Recordkeeping: Recent Recordkeeping Interpretations

This OSHA Recordkeeping training class will incorporate the lessons learned from OSHA’s recent Interpretation Letters into the existing OSHA recordkeeping analysis as well as OSHA’s current Frequently Asked Questions.

By : Compliance Online
Product Type : On Demand Webinar
Design History Files, Device Master Records, Device History Records, and Technical Files

This webinar will discuss in detail the existing and proposed requirements for the FDA's DHFs, DMRs, DHRs and the MDD's TF/DD.

By : Compliance Online
Product Type : On Demand Webinar
Record Keeping for a (Food) Recall: Keeping Records to Minimize the Affect of a Recall

This 90-minute Record Keeping for a Food Recall training will help you understand why records are a key factor in the recall decision and determination process for companies, customers and regulators.

By : Compliance Online
Product Type : On Demand Webinar