Skip to content

Health & care: Complying with FDA's Good Documentation Practices

FDA's Good Documentation Practices,Health & care, Psychology, Clinical psychology

NetZealous LLC

Summary

Price
£170 inc VAT
Or £56.67/mo. for 3 months...
Study method
Online
Duration
2 hours · Self-paced
Access to content
6 months
Qualification
No formal qualification
Certificates
  • Certificate of completion - Free
Additional info
  • Tutor is available to students

Overview

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


If an instruction or record is poorly documented, then the manufacture or Quality assurance/control of a product as well as patient safety can be negatively impacted. The standard of documentation within a company can directly impact the level of success in quality of products that are safe as well as success during audit situations. Consequently, GMP /GLP /GCP regulations from PIC/S, FDA, ICH and EU all include mandatory sections on documentation.

Description

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.

Areas Covered in the Session:

  • Basics of Good Documentation Practices
  • Documents vs records
  • How to write or record information in a compliant way (includes text, numbers, electronic signatures etc)
  • 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

Who is this course for?

  • Anyone that creates records in a regulated industry including Laboratory, Clinical and Manufacturing Staff, as well as IT /Software Staff

Questions and answers

Currently there are no Q&As for this course. Be the first to ask a question.

Ask a question

Certificates

Certificate of completion

Digital certificate - Included

Reviews

Currently there are no reviews for this course. Be the first to leave a review.

Leave a review

Legal information

This course is advertised on reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.
View all
Related searches: Online courses