Good Documentation Practices Course Overview

Good Documentation is necessary to demonstrate we work in a compliant manner. We will discuss some of the principles that lead to good or bad documentation, the regulations that are driving why we need good documentation, and then look at how to create good documentation, including examples of what to do or not do. Critical to Good Documentation Practices are the underlying principles of data integrity. Good documentation is presented in terms of the Data Integrity principles of ALCOA (attributable, legible, contemporaneous, original and accurate). This presentation supplements, but does not replace the more detailed presentation on data integrity.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Why Should You Attend

The goal of documentation should be to ensure compliance. However, failures in documentation and procedures represent more than half of the top citations by FDA. FDA is telling us we just don’t get it. To attempt to remedy this finding, this presentation will discuss the purpose of good documentation, what proper documentation looks like and a brief discussion of elements of good procedures as well as the records generated.

Key Learning Objectives

  • Learn General Principles of Good Documentation Practices
  • Learn applicable regulations related to documentation
  • Fundamental principles of data integrity
  • Principles of good instructions
  • Proper record correction
  • Common failures to avoid

Webinar Takeaway

  • General Principles and Key Definitions
  • Regulations (FDA and EU)
  • Documentation - Instructions
  • Basic Documentation Principles
  • Practical Record Correction
  • Common GMP Violations Found in Documents
  • Summary

Who Will Benefit

  • Quality Assurance
  • Document Control
  • Area Managers
  • Subject Matter Experts
  • All staff in pharma / biopharma and medical device industries

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FDA Faculty David W. Husman

David W. Husman, Ph.D., ASQ CPGP, RAC

Experienced Consultant in Pharmaceutical and Medical Device Industries |Trainer | Based in Greenville |Open to Traveling

Taylors, South Carolina

Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 20 years as a consultant to biopharma, pharma and device industries.

Experience has spanned from R&D to Commercial Manufacture

Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.