Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations.

This Software Auditing Procedure training will discussion on FDA software Standard “General Principles of Software Validation”, Actual FDA investigator software auditing techniques for software failure investigations.

This Design Control Inspection training will review of the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined.

This Webinar will describe, explain and clarify the differences between DHF, DMR and DHR . It will also detail the requirements and the expected contents of each record.

This contamination control training will focus on how to use the EM data appropriately as part of a contamination control plan and also discuss about Designing and Managing a Microbiological Monitoring Program.

This Webinar will highlight the requirements of ISO 17025 and ISO 34 and explain the preparation, testing of certified reference materials along with assessment of suppliers of reference materials.

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment to improve performance. Thus, the field version of the software is no longer the validated approved version.

This biotech training will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products.

Fundamental requirements for process validation in both FDA QSR and ISO 13485. Learn when a process should be validated, the basic components of a process validation (IQ, OQ, and PQ) and how to write protocols and reports.

This Water system compliance training/webinar focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches.

This Spread Sheet Validation training/ webinar explains FDA requirements for Excel spreadsheets used in production or the quality system. The regulations come from 21 CFR §820.70(i) Automated Processes and 21 CFR Part 11.

This Medical device training is a section-by-section review of ISO 13485 in a clear concise manner, and provides suggestions for development of a compliant system.

This system based inspection for Laboratory Control System training/webinar includes measures and activities related to laboratory procedures, testing, analytical methods development and validation or verification, and the stability program.

This FDA Inspection training will provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your PAI.

This Water system compliance training will guide you through the changes to implement to Validate Water system and better understanding of quality specifications and process control levels, as well as the microbiology of water systems.

This Medical device quality audits training review the process used by FDA to perform inspections of medical device manufacturers and will provide advice for quality and regulatory personnel that required providing information to an FDA inspector.

This Analytical laboratory audit training/webinar will show how to implement a GXP program and how to audit this program.

This Medical device training will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action.

This Objectionable Microorganism training will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

In this webinar you will learn how to determine the Root Cause origin of a problem. You will learn a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can prevent occurrences.