Quality & ISO 9000 Compliance Management Training

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.

This training program will enumerate the types of frauds that occur in the revenue cycle and cash receipts function. It will also highlight red flags or warning signs to look out for that may indicate someone is committing fraud. Further, attendees will learn to perform a cost benefit analysis to determine whether it makes business sense to correct a control deficiency.

Attendees will come away from this training program with a good understanding of upcoming changes to the ISO standard and the implication of those changes to the classification and operation of clean rooms in regulated industries.

This training program will discuss the new requirements of ISO 9001:2015. It will also detail risk management and how it relates to Kaizen/Lean efforts. Attendees will learn how to integrate all Kaizen/Lean practices with the quality management system as well.

This training program will help find the dots relating to AP internal controls and connect them. The course will include: processes of formulation and implementation; how to develop steps for internal controls; how to develop tools for internal controls; how to benefit from these tools and more.

This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system.

This webinar will explain the principles of lean and value stream mapping. Attendees will learn how to apply lean concepts to continuous improvement work across the quality system.

This webinar will explain how to implement an effective records management program. Attendees will learn the advantages of record management to ensure safety and security of data.

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 webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.

This 120-minute webinar will provide an overview of the ISO 14001 regulation, its benefits to organizations, the elements of auditing for ISO 14001 and training requirements. You will learn how to implement these standards at your organization ensure compliance.

This 90-minute Internal Audit webinar will cover the three foundational elements that support an effective Internal Audit program - establishing Internal Audit Program objectives, developing audit plans, and writing effective non-compliances.

This Software Project Management training is designed to help executives and managers set and deliver on appropriate and realistic expectations, and avoid the 90% Syndrome.

This Software Testing training will review a testing method based on 'Design of Experiments' to greatly reduce redundant test cases and ensure that maximum number of defects are found.