Good Documentation Practice

This interactive and engaging live online workshop will help you master the essential elements of managing the document lifecycle. You will learn about the vital components that will help you identify and address critical documents for the manufacturing, testing, control, and distribution of medicinal products.

Sessions:
09 – 10 March 2021 (4 hours per day)
or
07 – 08 September 2021 (4 hours per day)
09:00-13:00 CET

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We all know the saying, “if you didn’t document it, it didn’t happen!” and for a good reason. Documentation is a critical part of any GxP quality system. Therefore, mastering the essentials of Good Documentation Practice is essential for controlling operations and providing objective evidence of activities. Your processes may be state of the art, but the regulators can still shut everything down for inadequate documentation.

Therefore, to avoid such situations and to comply with regulations, you need to have your documentation under control.

This interactive and engaging online workshop will help you master the essential elements of managing the document lifecycle. Additionally, you will learn about the vital components that will help you identify and govern critical documents for

  • manufacturing
  • testing
  • control
  • distribution

Also, you will learn the best practice framework for Good Documentation Practice and various approaches that you can apply to all relevant areas of the document lifecycle.

Topics

  • Document lifecycle/types of documents overview
  • Data integrity
  • Document control
  • Good Documentation Practice
  • Document retention and destruction
  • Implementation of document control system

Target Group

This course is for anyone who works within a GMP driven organization and has to deal with documentation. It is essential that all documents, whether paper or electronic, are managed in compliance with good practices and data integrity principles to provide a full audit trail related to a product/batch such that the history is reproducible in the case of any issues. Therefore, this workshop is of particular importance to pharmaceutical quality professionals in all GxP fields

Event Details

The workshop lasts about 8 hours and spreads across two days.
That way, you don't get overwhelmed with too much information at once. Also, you can get back to your urgent projects after your launch break.

Start time: 09:00 CET

End time: 13:00 CET

765

Plus 19% VAT

Limited Spots Available

Your Instructor

Alex Hall

QP Trainer & Consultant

Alex is an expert in Pharmaceutical Quality Assurance with 30 plus years in the pharma industry, 20 of those as a Qualified Person. As an instructor, Alex builds on her experience and her previous role as a UK QP Assessor to support QA professionals and QP trainees. She helps trainees achieve the best results through supportive coaching, mentoring, and a straightforward training approach.

You can learn more about Alex from her appearance on The Qualitalks Podcast:

1. When You Deal With Risk, Don’t Be a Firefighter!

2. The Role of the Qualified Person (QP)

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What People Say About Our GMP Online Training

Our online interactive workshops will be presented to you live through a specialized classroom platform. You will be able to attend from home or work, yet feel like we share the same room.

Live Online
GMP Training

Communication

See and communicate with the tutor through a webcam and chat

Interactions

Raise your virtual hand to ask questions

Activities

Partake in polls and quizzes

Teamwork

Participate in exercises with other delegates

Let us Know Your Needs

Please share with us several suitable dates for private training sessions and the number of attendees. We will get back to you with a customized offer as soon as possible. 

Wait, don't leave empty-handed!​

Download our free FMEA guide, which is dedicated to GMP and pharma professionals.

This extensive yet simplified guide to Failure Mode and Effects Analysis (FMEA) will help you master one of the most vital instruments in your risk management toolbox.

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