Quality & ISO 9000 Compliance Management Training

With the release of ISO 9001:2015 September 23, 2015, now is the time to prepare. This 9001-2015 Risk Based Thinking training program will highlight the changes from the ISO 9001:2008 revision. A key change is the addition of risk based thinking, and the training includes group exercises to reinforce this new process.

Simulations and Monte Carlo methods are powerful tools in quality improvement. They can help explore proposed changes to methods and processes and avoid potential problems. They can also help optimize QMS activities. In this presentation, attendees learn methods in Excel, which means that projects do not need special purpose and expensive software packages.

The largest cause of recalls which will normally lead to product liability lawsuits is “Defects in Design.” The product’s design specification was defective right from the start, which wasn’t caught or handled properly, and then manufacturing management made sure all the products were manufactured per that [defective] specification. This training program will briefly cover all the procedures that need to be in place and followed during new product development.

This training program will highlight all the key areas that need to be under control or can lead to product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations.

The new ISO 9001:2015 requires companies to establish context of the organization and utilize this perspective along with the new High Level Structure (HLS) Clauses. This webinar is designed for quality assurance managers, management representatives, ISO 9001 implementation teams, and quality management system auditors. With the release of ISO 9001:2015 in September 23, 2015, now is the time to prepare. This 9001-2015 Transition Overview course will highlight the changes from the ISO 9001:2008 revision.

This webinar will highlight the current statistics and trends regarding product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations. It will also identify all the areas of manufacturing management that are typically not being handled properly and contribute to such failures, from product development thru marketing, product testing, supplier selection and control, document management, contracts and agreements, manufacturing quality, and incident investigation.

This webinar on FDA's design control requirements will discuss how a requirements management approach consistent with the CMMi Requirements Management KPA, helps companies meet FDA's Design Control requirements.

This training program will discuss how to effectively create performance metrics and goals for your department or project. It will also discuss the key components of a metric and when to use different types of performance metrics.

This training program will provide tools require to understand what a good Request for Proposal (RFP) looks like, how to write one, and how the job of selecting a vendor becomes easy when these tools are employed.

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

In this Quality management training you will learn how to develop thorough maintenance documents that are clear and confusion-free and you will discover how to perform and document corrective work in a manner that eliminates ambiguity.

This Internal Quality Audit training is presented as a practical way for an organization to evaluate its internal audit program and make required improvements.

This Quality inspection training will teaches tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a manner such that they stay resolved in a GMP compliant manner.

This AS9100 Rev.C training will cover the changes made in Rev.C and how it might impact your organization including the additional requirements associated with Risk Management.

This CAPA training/webinar for Medical device will guide you how CAPA and complaint handling should interact in Medical Device and it will mention the Differences between the FDA's approach and the ISO approach.

Emphasis will be placed on realizing system interactions and cultural environment that often lies at the root of the problem and prevents true root cause analysis. This webinar will benefit any organization that wants to improve the effectiveness of their CAPA and failure investigation processes.

This Quality management training will guide you Implement Risk Management Principles and Activities within a Quality Management System & ISO-based Quality Management System Reviews.

This Quality management training will review processes for integrating a reasonable level of risk management into the quality management system.