Course overview

Process Validation & Equipment Qualification

Effective validation is essential to ensure compliance and quality. But many professionals don't feel fully confident engaging in these activities. That's why we've designed a one-day course for you to gain a deeper understanding of process validation and how you can guarantee compliance in your organisation.

Process validation and equipment qualification are core disciplines in regulated life sciences manufacturing to demonstrate product quality and compliance. This comprehensive 2-day course will give individuals a greater understanding of the requirements of regulations in the EU and US, plus practical examples of how to meet them.
Format 

Virtual
Instructor-Led

Date / Time

Select your date below

Price

€1,100

Duration

16 Hours

Time

1pm - 5pm

Time Zone

GMT

Course Information

Course Syllabus 
Dates & Prices
What's Included
Technology Requirements
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Training Dates

Training Times

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Discounts 

Group booking discounts are available as followed:

• 3 – 5 attendees receive 15% discount
• 6 or more attendees receive 20% discount

Email our team at [email protected] and one of the team will provide you with your unique discount code or invoice. 

More than 8 attendees?

If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

What Is Included?

▪    Direct, live access to an expert trainer
▪    Access to the Meddev Solutions Training Portal
▪    Access to the training recordings for 3 months
▪    Fully Interactive Course - Polls, quizzes and breakout sessions 
▪    Downloadable Resources 
▪    CoE Accredited Certificate of Completion
▪    Knowledge Checks
▪    Full Tutor Support 

Course Agenda

This training course will explore the following topics:

Module 1:                                       
Welcome & introduction 
- Aims, objectives & structure
 
- What is process validation
 
- What regulations, standards and guidance applies to process validation
 
- Which processes require validation
 
- The process validation process

Module 2:                                            
 - How process validation links with product development
 - Building a team
 - Risk based approach to process validation
 - Mapping the process to be validated
 - How to develop a Validation Master Plan (VMP)

Learning Objectives

By the end of this course you will be able to:

  • Understand the key concepts of process validation and the associated benefits
  • Appreciate how process validation links with the product development process
  • Understand how ISO 13485, regulations and guidance (such as the IMDRF) applies to manufacturers of medical devices
  • Correctly Identify when a manufacturing process requires validation
  • Describe the elements involved in performing process validation from planning to execution
  • Explain how to apply a risk-based approach to process validation
  • Illustrate the importance of a validation master plan (VMP) and validation protocols
  • Apply concepts learnt to develop a comprehensive VMP
  • Understand the difference and purpose of installation (IQ), operational (OQ) and performance qualification (PQ)
  • Apply concepts learnt to develop IQ, OQ and PQ protocols
  • Define and create relevant acceptance criteria
  • Understand and apply common statistical techniques used in process validation
  • Outline how to maintain a state of validation through the lifecycle (Including revalidation)

Who Should Attend? 

This training course has great value for anyone who needs an understanding of or is engaged in validation activities.

Audience learning level: Basic to intermediate

Technology Requirements

Operating system
Windows requirements: Windows 7 or later
Mac requirements: Mac OS X Yosemite 10.10 or later
Linux requirements: 64-bit, Ubuntu 14.04+, Debian 8+,openSUSE 13.3+ or Fedora Linux 24+

Processor
Windows requirements: Intel Pentium 4 or later
Mac requirements: Intel
Linux requirements: Intel Pentium 4 or later

Internet connection
Required

Zoom

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.

Don't just take our word for it

Witness it first hand, directly from our previous attendees 
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Meet your instructor

Rod Beuzeval

Regulatory CoE & Trainer 

Rod is a Regulatory and Clinical expert with 22 years’ experience in regulated pharmaceutical and medical device companies and holds a RAPS RAC Global scope certification. Rod develops and routinely delivers training on EU MDR, MDSAP, ISO 13485, Risk Management, Clinical Data Evaluation and consulting on projects within this realm. 

Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. 
Rod Beuzeval

Training for your team,
your way

We understand that every company is different and face unique challenges everyday. At Meddev, we can tailor any of our courses around your organisation’s specific needs and products. 

Bespoke learning experience

Develop your course with a leading subject matter expert to meet the specific needs of your organisation

Maximise your budget

Cut unnecessary costs and allocate your budget on what matters most

Track employee progress

Keep track of your employees’ progression in your own workspace

Frequently asked questions

When will I receive the course confirmation details? 

Once your booking has been placed and confirmed, you will receive an email which contains your course overview, login details, course agenda and payment receipts. You can begin your training immediately!

What is included in the course?

▪ Direct, live access to an expert trainer
▪ Access to the Meddev Solutions Training Portal
▪ Fully Interactive Course - Polls, quizzes and breakout sessions
▪ Downloadable Resources
▪ CoE Accredited Certificate of Completion
▪ Knowledge Checks
▪ Full Tutor Support 

Is this course live?

Yes! This course is completely live with a Centre of Excellence approved industry-expert. You can ask questions throughout the course as if you were in a real classroom. 

Do I get a course certificate?

On successful completion of the course, you will receive a certificate of completion that can be used to demonstrate your knowledge to your employers and Notified Bodies. 

What payment methods do you accept?

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, and you require a PO, please email our team at [email protected]

Do you offer group booking discounts?

Absolutely! 3 – 5 attendees receive a 15% discount and 6 or more attendees receive a 20% discount. If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

Can I transfer my place to another colleague?

Yes of course. If you can no longer attend the course, you can transfer your place at no additional cost.

What application do you use for the training?

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
Ready to get started?