Deviations and Issue Management Systems

Deviations cause a lot of stress, waste time, money, and may affect compliance. And this interactive and engaging live online workshop will help battle all that.

You will master the essential elements for investigating deviations that arise during the product life cycle of medicinal products and learn how to document and address deviations much more effectively.

At the end of the 2-day session, you will know how to reduce the reoccurrence of deviations in your organization and minimize overdue issues in the QMS.

As a result, you will boost your compliance, improve KPI, and save much time and money in the process.
Besides, fewer deviations mean less stress at the workplace and a much healthier business environment.

Date and Time::
27 – 28 July 2021 (4.5 hours per day)
09:00-13:30 CET

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Mishandling deviations and failing to investigate them correctly can lead to serious compliance problems. Hence, regulators can shut-down your operation in a blink of an eye. Additionally, not addressing deviation properly leads to reoccurring issues, which waste time and are a killer of productivity. Therefore, each GMP professional must know the correct framework to deal with such issues quickly and effectively.

This interactive workshop covers the essential elements for investigating issues that arise within a product’s life cycle. It includes the manufacturing, testing, control, and distribution of medicinal products.

It provides a best practice framework for analyzing deviations and implementing corrective actions. Additionally, it teaches you approaches to apply to all relevant areas of the product life cycle and supply chain, which includes:

  • Product quality complaints,
  • audit findings,
  • laboratory Out of Specification / Out of Trend results

The approaches will help you:

  • document deviations quicker and more effectively,
  • drive continual improvement to your systems,
  • reduce the number of reoccurring deviations,
  • minimize the number of overdue deviations in the system
  • become more effective and reduce stress.

Topics

You will learn and practice:
– The deviation/investigation Process
– The correct way to document deviations
– How to perform effective Impact/Risk assessment
– How to efficiently investigate events
– How to design effective CAPAs and follow-ups
– Implementation of Deviation/investigation process

Agenda

Download Agenda

Target Group

This course is of particular importance to quality professionals in all GxP fields (pharma, medical devices, cosmetics, dietary supplements, and food).

If you have to deal with and investigate errors, this workshop is for you.

In a GxP environment, you must examine all issues, errors, and near -misses appropriately. That way, you can ensure that you have correctly assessed the impact and risk, assigned relevant corrective actions, and prevented future issues. This workshop will teach you how to do that most efficiently.

Event Details

The live virtual workshop lasts 9 hours and spreads across two days.

27 - 28 January 2021 (4.5 hours per day)
09:00-13:30 CET

Join us online from home or office, alone or with colleagues.

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First day of the  2 -day workshop:

Date: July 27, 2021

Start time: 09:00 CET

End time: 13:30 CET

Email: service@qualistery.com

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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