Essential Regulatory Strategies for Medical Devices on the Class II / III Cusp
Bob Michalik, JD, RAC Michalik
60 Min
Product Id: 700253
In this webinar, essential tactical tools will be discussed in detail with examples of when to apply one and not another The tactical tools will be presented in the framework of an overall regulatory strategy so you can see the “forest for the trees” and effectively communicate your plan to senior management, the development team, and most importantly, to government regulators
'Performing effective supplier audits: a coming FDA compliance focus'
Dennis Moore
60 Min
Product Id: 700436
his presentation will cover auditing and management techniques in relation to purchasing control compliance. Real supplier auditing processes and other management tools associated with purchasing controls will be discussed Many firms feel that they are adequately auditing and managing suppliers, yet find they are having myriads of quality issues. FDA and other auditing organizations are going to focus on supplier auditing compliance in 2007-2008
Understanding FMLA: Family and Medical Leave Act
Jarik E Conrad
60 Min
Product Id: 700546
This workshop will provide an overview of FMLA and its provisions, as well as guidelines for how to manage its use effectively. The number of women in the workforce is increasing at a faster rate than men; in fact, they will make up 48 percent of the workforce by 2010.
Practical tips to comply and implement the Adverse Event Reporting requirement of the new Dietary Supplement and Nonprescription Drug Consumer Protection Act
Ashish Talati
60 Min
Product Id: 700754
The Webinar discusses recordkeeping requirements of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor. The Dietary Supplement and Nonprescription Drug Consumer Protection Act law mandates reporting to the Food and Drug Administration (FDA) of serious adverse events for dietary supplements.
Cleaning Validation - Chemical & Microbiological Aspects
Nazia Dar
60 Min
Product Id: 700790
This Webinar will explain how to write a Cleaning Validation Master Plan. This webinar will discuss that what are the critical elements have to be considered when designing a cleaning validation program at a Pharma plant.
Suggestions for individuals to check and safeguard confidential data
Deborah Donaldson
60 Min
Product Id: 700634
This webinar focuses on the regulatory requirements surrounding this issue, steps that a company can take to mitigate the risk of loss or exposure, and ways that consumers can participate in the protection of their own information. This webinar will provide valuable assistance to all regulated companies that need to safeguard confidential customer data.
Developing a Robust CAPA System
Ronald Schoengold
60 Min
Product Id: 700550
In this webinar instructor will explain what are essential elements of CAPA system to meet current regulatory requirement and how to achieve it The basic CAPA procedure should clearly define the fundamental elements for developing CAPA files which address significant quality system non-conformances
Introduction to Statistical Process Control (SPC)
Lawrence Mucha
60 Min
Product Id: 700343
This session will introduce advanced control charting for multiple stream processes. We will also introduce control chart analysis and how to select the correct control chart and interpretation and reaction to control chart signals.
HR Compliance Requirements for small Companies
Matthew W Burr
60 Min
Product Id: 700649
This webinar will cover Federal Labor Laws by number of employees and adherence to State Laws.
Applying Lean Documents to a Project - how to create a project file, follow design controls, yet maintain a lean set of project documents
Jose Mora
60 Min
Product Id: 700358
Using the lean document approach, documents are written by the authors with the highest level of expertise, and information is presented in a simple, organized way This webinar explains the use of lean document principles and presents a step-by-step approach to creating a Design History File, a Device Master Record, and other key supporting documents
Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971
Edwin L Bills
60 Min
Product Id: 700713
The presentation will review the complete requirements for Risk Analysis and give an example of how a company can easily create a Risk Analysis in full compliance with the standard. The information will assist in meeting various national and global regulatory requirements for medical devices.
ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products
John E Lincoln
60 Min
Product Id: 700708
An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry.
1825 Sexual Harassment Prevention Training
Scott Baird
60 Min
Product Id: 700596
This program teaches the employees of your organization what harassment is and what their responsibility is in reporting and preventing it. It is a sensitive topic, even though major portions of the work force, both men and women, have been affected.
Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation
Dennis Moore
60 Min
Product Id: 700192
Detailed analyses of the sections of the QSR design control regulations that have requirements not present in the ISO 13485:2003 standard. Many companies are confidant that their ISO 13485:2003 design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue.
Cleanroom Operation, Maintenance and Operators
Nazia Dar
Product Id: 700630
Attendees will learn and understand the do’s & don’t of the cleanroom procedures during cleaning, disinfecting, transferring of material and filling operations. This one-hour online seminar is designed to discuss the principles applied to the operation and cleaning of cleanrooms to ensure the contamination control.
Email Usage/E-Compliance - Don't Get Caught on the Bottom of the Spamming Pile
Sheila Rae
60 Min
Product Id: 700548
With the fast growing world market and the desire to communicate in a fast and effective manner, many of us rely on instant communication to make client connections.
A Beginners Guide to Importing Medical Devices
Jennifer Diaz
60 Min
Product Id: 700701
This seminar is intended to assist with a basic overview of what medical devices are... Seminar is to inform the international trade and transportation community regarding the FDA policies and procedures related to medical devices.
Infection Control Commissioning for Health Care Construction Projects
Laurence Lee(CIH)
60 Min
Product Id: 700700
This webinar will provide valuable assistance to all healthcare organizations and institutions; architecture and construction management companies; infection control practitioners and industrial hygienists; joint commission verifiers and reviewers, and construction companies engaged in healthcare construction projects.
How to Put Together An Effective Audit Program
Deborah Donaldson
60 Min
Product Id: 700285
This program will lay the foundation for subsequent webinars. but can be used as a starting point for the development of any audit program. The goal is to have a program that is comprehensive enough to guide the auditor(s) through the testing of an adequate number of areas, the documentation of the findings and conclusions based on quantitative data, and the presentation and recommendations based on the findings
Effective Method Transfer of Complex Bioassays
Ana Menendez
60 Min
Product Id: 700636
This Bioassays training/webinar will systematically outlines the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.