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Health & Medical - Documentation & Proceedings

> Conference documentation, webinars & Proceedings

3-hr Virtual Seminar - China: Compliance Processes for Life Science Products

This 3-hr virtual seminar on compliance processes for life science products in China will discuss the regulatory structure and requirements for compliance with Chinese SFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

By : Compliance Online
Product Type : On Demand Webinar
Understanding and Implementing ISO 17025

This webinar will provide a detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation. You will learn steps towards laboratory accreditation and how to prepare for an ISO 17025 audit.

By : Compliance Online
Product Type : On Demand Webinar
The U.S. FDA's New Global Engagement Initiative

This 90-minute webinar will discuss the new FDA "Global Engagement" Initiative for new areas for heightened CGMP compliance from U. S. FDA-regulated companies and their global partners. It will cover areas for increased awareness, focus, and remediation, and the approaches that are now mandated.

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
FDA Warning Letter Closeout Program - Webinar

This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA.

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
The 21 Elements of a 510(k)

This 90-minute webinar will review the 21 basic elements that need to be addressed in the traditional 510(k) submission, as required by the FDA.

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
FDA Warning Letter - Consent Decree Software Validation

This webinar/training will discuss what to do to avoid additional software related compliance along with the response steps where the citations that directly or indirectly include automated system.

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
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
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
Calibration and Qualification in Analytical Laboratories Webinar

This webinar will provide a detailed understanding about calibration and qualification of laboratory equipments, development of a qualification master plan, allocation of equipments to qualification categories A, B, C, and the approach for qualifying existing systems.

By : Compliance Online
Product Type : On Demand Webinar
Sample Prep The Achilles Heel for Pathogen Detectionand Early Disease Diagnostics
Sample Preparation for Virus, Toxin & Pathogen Detection & Identification 2012

Sample Prep is a recognized event for experts in sample preparation for detection and identification of viruses, toxins and pathogens. The conference focuses on the major issues and current state-of-the-art in the technologies related to the important phases of "real world" sample preparation

By : Michael Heller, University of California San Diego
Product Type : Business Conference
Advances in Sample Preparation using Microfluidic Technologies
Sample Preparation for Virus, Toxin & Pathogen Detection & Identification 2012

Sample Prep is a recognized event for experts in sample preparation for detection and identification of viruses, toxins and pathogens. The conference focuses on the major issues and current state-of-the-art in the technologies related to the important phases of "real world" sample preparation

By : Raymond Mariella, Lawrence Livermore National Laboratory
Product Type : Business Conference