FDA Documentation and IT Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar on SOPs will instruct you in creating, managing and implementing adequate SOPs that can impress even the FDA inspectors.

This 3-hr virtual seminar on the Electronic Common Technical Document will help you understand the background, technical aspects, document structure, and use of the electronic Common Technical Document.

This FDA Good Documentation Practices training will introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.

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.

This Spreadsheet validation training will cover the use of spreadsheets to report data from the inception of the spreadsheet (user requirement specification), through the development process, validation, and use.

This 21 CFR Part 11 training will deliver concrete guidance which will provide a roadmap for compliance that will have immediate benefits, withstand FDA’s changes to Part 11, and discuss the new Obama administration approach to enforcement.

This FDA Inspection training will examines the audit process and how to manage Process Deviation Investigations.

This Validation training will explain the intent and importance of process validation. Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.

This presentation will give an overview of the FDAAA and summarize the new provisions pertaining to specialized pediatric medical device development, food safety, advisory committee provisions, clinical trial registries and drug safety enhancement.

In this presentation, we will look at these documents from the investigator’s point of view, reviewing the FDA training manual and actual FDA warning letters and responses. This will reveal what the investigator is trained to look for and what types of problems are actually being discovered in the field offices.

We will discuss methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.

In this FDA compliance training learn regulatory expectations for stability indicating methods & Purpose and requirements for stability indicating methods. There is a lot of concern related to the stability of various drugs over different periods of time and different companies are following different approaches to this problem.

This session describes how to use the GAMP® standard to determine what has to be validated and explains how to create documentation that will meet regulatory requirements worldwide.

This presentation covers all of the steps one should take when beginning the IDE process for a PMA.

This presentation will cover laboratory-related warning letters that contain 483s related to regulatory issues that affect pharmaceutical companies. While recent warning letters will receive the heaviest scrutiny, we will also cover old warning letters that serve to illustrate important points.

Understand why the VMP is a project management tool and why it’s a living, breathing document. This webinar will provide valuable assistance and guidance to all life sciences manufacturers that are preparing to use or are currently using validation master plans to bullet-proof their validation programs.

The webinar will address each audit item and train the participants how to determine the compliance status. We will use common examples of non-compliance observations from actual audits and suggest remediation plans that are compliant, efficient and economical.

AN overview of the Part 11 regulation, with special emphasis on the key role played by the applicable predicate rules as the starting point for any Part 11 compliance assessment. In spite of the FDA’s clarification regarding the scope of electronic records subject to Part 11 as expressed in the Sep 2003 Guidance for Industry, much discussion and debate still surround the topic.

The mutually exclusive roles for Quality Assurance and Quality Control in validation will also be discussed. Across 20+ years of global regulations and guidance related to computer systems, there are four common themes that provide the foundation for auditable validation efforts.

This 21 CFR Part 11 training/webinar will provide valuable assistance to all regulated companies that need to comply with 21 CFR Part 11.