Quality & ISO 9000 Compliance Management Training

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 course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

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.

New ISO standards, including ISO 9001, will include additional requirements related to climate change. These fortunately do not involve carbon neutrality goals, but do require organizations to consider climate change and also potential requirements of relevant interested parties.

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to “listen” to their processes so that potentially harmful changes will be quickly detected and rectified.

However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility. Highly effective SPC programs combine technical competencies, such as using an appropriate chart and sample size for the application, with effective management techniques such as enabling operator buy-in and involvement. This webinar identifies and describes ten keys that unleash the power of SPC.

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.

This ISO 9001:2008 training will provide an understanding of the changes and requirements that Internal Auditors in ISO 9001 certified organizations will need to address to be compliant to the new ISO 9001:2008 revision.

In this Lean six sigma training we will explore what early adopters are doing – and what is on the horizon and a brief history of the evolution both LSS (Lean Six Sigma) in SCM (Supply Chain Management).

This AS9100 compliance training will provide an understanding of the changes and requirements AS 9100 certified organizations will need to address to be compliant to the new AS9100 Revision C Standard.