'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
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.
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
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
Quality Planning Process and Procedure
Ronald Schoengold
60 Min
Product Id: 700665
This Quality Planning training/webinar will define the Quality policy and plan with the help of procedure, Manual and templates where manufacturer decides how to apply these regulatory guidelines in developing a plan that consistently delivers high quality products and services.
The New Dietary Supplement Good Manufacturing Practices
John Suzuki
60 Min
Product Id: 700642
This New Dietary supplements webinar will highlight from a quality perspective the introductory requirements of these new CGMP regulations and examine methods and strategies for meeting these new requirements.
Introduction to statistical Design and Analysis of Experiments (DOE)
Lawrence Mucha
60 Min
Product Id: 700344
This statistical Design and Analysis of Experiments webinar will introduce DOE and process modeling.
Quality & Finance: Creating a Balance Using Lean Principles
Tom Zidel
60 Min
Product Id: 700551
This healthcare webinar will give an introduction to lean in healthcare which includes an illustrative exercise to aid participants in understanding the basic underlying concept of lean.
How to set up a small-volume radiopharmaceuticals manufacturing facility
Shankar Seetharaman
60 Min
Product Id: 700475
This Radiopharmaceuticals training will set out guidance and advice for those interested in setting up or improving an existing facility. Radiopharmaceutical manufacture is starting to begin a new phase as FDG now has a product licence
Process-Based and Metric-Driven Internal Audit Approach
Angelo Scangas
60 Min
Product Id: 700401
This Internal Audit Approach training/webinar is designed to enhance your understanding of process auditing techniques Using interactive examples and a case study.
Five Steps in Conducting Audits - ISO 19011
Jayne Pilot
60 Min
Product Id: 700284
Pilot has provided training in auditing since 1995 using her Three Step System Approach for Auditing and her Five Steps in performing audits This presentation cover in simple terms the five steps to conduct audits and the working documents required. 1 - Initiating, 2 preparing, 3 Conducting - opening/closing meetings, collecting evidence, findings, 4 Audit reports, 5 Audit completions.
Management Controls needed for an effective QMS to meet FDA QSR and ISO 13485 regulations
Susan C Reilly
60 Min
Product Id: 700134
This Management control training will provide the principles and practices needed to effectively develop and implement the Management Controls to ensure an effective Quality Management System and to comply with the FDA QS Regulation.
Project Manage Your Validation Project -- An Overview
Lawrence Mucha
60 Min
Product Id: 700367
This Validation training will provide valuable assistance to all regulated companies that need to validate their systems. Project management is the application of knowledge, skills, tools, and techniques to manage project activities to meet project requirements
An Overview of Design and Development Planning
Ellen Golds
60 Min
Product Id: 700380
This training will identify and review the key planning documents, including team assignments, management and conduct of the project, project phases, and regulatory requirements and scheduling.
From CAPA to Capability: Shifting the Focus to Profitability
Barbara Johnson
60 Min
Product Id: 700377
This Quality training will help you look holistically at your quality systems and embrace a continuous improvement approach that will drive quantifiable business benefits. A quick review of your log of corrective and preventive actions can be quite revealing. Many executives have found that their past improvement initiatives only addressed problem areas regarding individual products.
PET Container Stress Cracking - Mythology and Science
Stephen Zagarola
60 Min
Product Id: 700360
In this Packaging & Labeling training we take on what is probably P.E.T. greatest nemesis -- especially for those manufacturing and using P.E.T. Bottles in warm climates.
Introduction to Validation of Measurements (Gauge R&R)
Lawrence Mucha
60 Min
Product Id: 700341
This Validation training will provide valuable assistance to all regulated companies that need to validate their systems and will introduce measurement validation using Gauge R&R. Will introduce measurement validation using Gauge R&R. R&R standing for Repeatability and Reproducibility
Internal Auditing Essentials for Medical Device Manufacturers to comply with FDA QSR and ISO13485
Susan C Reilly
60 Min
Product Id: 700135
The principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485. This medical Device training will provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485.







