if-it-is-not-written-down-it-did-not-happen-complying-with-fda’s-good-documentation-practices

If it is not Written Down, It did not Happen: Complying with FDA’s Good Documentation Practices

Live Webinar

  • 60 minutes
  • 17 Days Left
     Sep 12, 2019
  •   01:00 PM - 02:00 PM ET
    10:00 AM - 11:00 AM PT

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety. Documentation provides both:

  • Information on when, where, who, why and how to complete tasks

  • Evidence proving that the tasks have been completed as they should be.

Join this session with expert speaker Richard Chamberlain, where he will discuss how to write or record information in a compliant way (includes text, numbers, electronic signatures etc)

Session Highlights:

  • Basics of Good Documentation Practices

  • Documents vs records

  • How to amend documents or records in a compliant way

  • Specific contents will include but are not limited to:

  • Document Creation

  • Document Approval

  • Handwritten Entries

  • Copies of Documents

  • Document Maintenance

  • Document Modification

  • Warning Letters for GDocP

Why You Should Attend:

As the FDA and TGA say “If it isn’t written down, then it didn’t happen” To meet industry standards, it is critical that all documentation follows GDP when it affects:

  • GMP / GLP / GCP processes

  • Material or product identity, quality, purity, strength and safety

  • The validated state of GMP / GLP / GCP product manufacture, facilities, equipment, computer systems and testing methods.

It is recommended that your company has a policy or procedure outlining the expected GDocP standards, particularly for those requirements that may be unique to your company – for example, using a specific pen color or when and how to use scanned documents/records as original data.

Who Should Attend:

GDP's are meant for use in the production and control of Active pharmaceutical ingredients (APIs), Medical devices, Excipients, Pharmaceutical products, Labs, Dietary supplements and Food ingredients:

  • Regulatory

  • Compliance

  • Audit

  • Quality

  • R&D

  • Scientists

  • Documentation and Validation

  • Clinical Research

  • Lab Managers

  • Engineering and Manufacturing


*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Richard  Chamberlain

Richard Chamberlain

Richard Chamberlain has a Ph.D. in Statistics and has consulted with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of Computer Systems Validation, Data Management, computerized project scheduling, strategic planning, and Quality Management. He has assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and Compliance to Regulations.

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