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

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.

This Part 11 - Electronic Records webinar will provide an insider’s view FDA’s current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).

This FDA compliance training will review the FDA Software Standard "General Principles of Software Validation". The process that FDA investigators use relative to software failure investigations will also be discussed.

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

This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.

This FDA compliance training will explain how to measure and reduce the FDA recordkeeping burden.

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.

Understand the 10-step risk based approach to validation, explore methods to decrease resource requirements, and learn how to make documentation more manageable and understandable.