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.
Implementing a Comprehensive Vendor Management and Oversight Program
Deborah Donaldson
60 Min
Product Id: 700293
This webinar will provide valuable assistance to all regulated companies that utilize third party vendors that provide products or services to the companies or to the customers or clients of those companies The most critical areas focus on the identification of the need for additional third-party services, development and adoption of the Vendor Management and Oversight Policy, the selection of qualified vendors (including the development of the Request for Proposal and bid process), the contract development and award, ongoing review, and nondisclosure and confidentiality concerns
How to Audit the Difficult Areas of a Quality Management System
Larry Whittington
60 Min
Product Id: 700334
This webinar will provide guidance on how to audit the more difficult areas of a quality management system The applicable ISO 9001:2000 requirements will be examined for each of these difficult areas and then suggestions made on how to more effectively audit them
ISO 27001: The risk assessment, control selection and risk treatment plan
Alan Calder
60 Min
Product Id: 700300
In this Quality compliance training topics will be related to the risk assessment, control selection and risk treatment plan for developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005. This is a part of a series of webinars that support those considering or developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005.







