Compliance Training Webinars for Regulated Industries

This Complaint Handling training will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback.

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.

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.

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.

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

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.

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.

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

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.

In this Risk Based Validation training we will go through various scenarios and recommend actions for validation and other controls.

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

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

In this Medical device training will provide valuable assistance to regulated companies on how to drive regulatory compliance for IT based medical devices.

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").

This Pharmaceutical training will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations.

In this Risk management training we will review the concept of Risk Management, its various elements, what is required, and its benefits. How are you meeting the FDA and ISO risk management requirements? Hazard Analysis? FMECA? dFMEA/pFMEA? The concept of Risk Management and the difference between risk analysis, evaluation, assessment, and management.

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.

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

This webinar will provide valuable assistance to all GSA Schedule contractors. It takes more than a GSA contract number and a sales team to be a successful GSA contractor. It also takes a well-designed and effective GSA compliance program.

In this Medical device training understand the expectations of FDA and the EU in applying risk analysis to medical devices. Risk Management is required by ISO 13485 and risk analysis by the FDA’s Quality System Regulations (QSR) and by of the EU medical device regulations. Using practical examples, this course look at the regulatory and reporting requirements of EN ISO 14971, "Medical devices - application of risk management to medical devices".