
Training Requirements and Practices to Assure QSR and ISO Compliance
Jeff Kasoff
60 Min
Product Id: 700316
This Medical device training will instruct on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to document training. To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them.

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.

Virtual SOX Compliance
Bob Benoit
60 Min
Product Id: 700405
Virtual SOX is one of the first open doors to effective and efficient sox compliance pathway. Using technology and local administrative talent we can gather backup documents, scan, upload and observe access controls. The concept of performing a Section 404 effort completely remote requires us to have a very different paradigm shift.

GSA Schedule Compliance - What's important now?
Tomi Bryan
60 Min
Product Id: 700328
In this GSA compliance training we look back at the most notable GSA Schedule contractor violations of the year and how to keep those from happening to your company.

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.

Complaint Handling and Management: From Receipt to Trending
Jeff Kasoff
60 Min
Product Id: 700319
This Complaint Handling training will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback.

Quantitative Approach to User Requirements Risk Assessment
Vimarie Ortiz
60 Min
Product Id: 700390
This Risk management training offers a quantitative risk management approach you can use to measure system implementation and enhancement efforts against the criticality and business/regulatory significance of the system.

GSA Schedule Recordkeeping - the 21 Documentation Libraries every Schedule contractor must have
Tomi Bryan
60 Min
Product Id: 700327
This GSA compliance training will provide valuable assistance to all GSA Schedule contractors and will review the 21 documentation libraries that every Schedule contractor should have.

Cleanroom Design, Certification & Classification
Nazia Dar
60 Min
Product Id: 700404
This Pharmaceutical training will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing. This seminar is designed to provide a thorough understanding of the principles applied to the design, qualification and operation of cleanrooms.

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.

CAPA Essentials - core principles and practices needed to implement an effective and efficient CAPA process
Susan C Reilly
60 Min
Product Id: 700299
This program is designed for the medical device, IVD, and combination product industries This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process

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.

Risk Based Validation of Software and Computer Systems
Dr. Ludwig Huber
60 Min
Product Id: 700339
In this Risk Based Validation training we will go through various scenarios and recommend actions for validation and other controls.

Understanding the systems to support compliance with GSA Schedule IFF, TAA and Price Reductions Clause requirements
Tomi Bryan
60 Min
Product Id: 700326
This GSA compliance training explains how an effective GSA Compliance program must be based on a systems approach. GSA Schedule audits are on the rise and so are the cost of fines and penalties. Given the current environment, it is imperative that GSA Schedule contractors have effective GSA compliance programs in place

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

Medical IT Device Security: Why Medical Device Manufacturers Must Take the Lead and Drive Regulatory Compliance
Lori Kahler
60 Min
Product Id: 700351
In this Medical device training will provide valuable assistance to regulated companies on how to drive regulatory compliance for IT based medical devices.

Parallel trade of medicinal products in the EU - Latest case law and Commission decisions
Jose Mora,Hector Armengod
60 Min
Product Id: 700198
This Medical device training will talk about recent developments in the European Commission’s approach towards the parallel distribution of medicines. In the past the European Commission has taken a strong stance against restrictions imposed by pharmaceutical companies on wholesalers and distributors of medicines, preventing them from parallel importing the contract products within the European Union ("EU").

Bringing FDA Pharmaceutical GMPs into the 21st Century
Tony Dunbar
60 Min
Product Id: 700346
This Pharmaceutical training will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations.