Data Integrity Training

Data Integrity training is a critical element in the development, implementation and operational delivery of a data integrity program. Ensuring compliance with the evolving data integrity guidelines from the MHRA, FDA and other regulatory bodies is a major challenge for pharmaceutical manufacturers, contract organisations (manufacturers, research and laboratories) and system suppliers.

During regulatory or client/customer inspection, your organisation will need to demonstrate that your staff have a suitable level of data integrity knowledge and are competent to develop key components, delivering the key activities. Training records and competency are easily inspected during regulatory inspections and very often a source of inspection findings for the MHRA and FDA.

Our tutors are industry experts, many have worked in the IT/computer systems arena for many years, providing consultancy, auditing and training to the pharmaceutical, biotech and healthcare industry across the UK, Europe, Asia and the U.S.A.

David Thompson, Managing Director and Principal Consultant at Clarity Compliance Solutions is a Data Integrity subject matter expert. He is a Chartered Engineer with both the MIET and the MInstMC and a member of the GAMP MES SIG.

Open Forum Courses - Held across various locations, with multiple company attendees, allowing for excellent networking opportunities. We run our courses periodically throughout the year, please contact us for dates and full details of the training dates.

In-House Courses - Held at a convenient location, tailored to meet the specific needs for your organisation, allowing you to work through real issues in the privacy of your own team. We tailor the courses to meet your companies needs, enable your team to cover the technical syllabus of the course while also working on some of your real operational or project issues in the privacy of your own team and offices. Please contact us for further information and to discuss your requirements in more detail.

Mix & Match - Training and Consulting

We can deliver courses and include an element of ad-hoc Data Integrity consulting or high-level system assessments. Many of our clients have found adding ad-hoc consulting very beneficial.

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Course Title

Date

Duration

Location

Courses

Course Title

Data Integrity Training

Aimed at Management and Supervisory roles. Understand the current regulatory expectations regarding Data Integrity threats and issues. You will be able to implement DI Governance systems, methodologies and programs.

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Date

Available upon enquiry

Duration

1 Day

Location

Available upon enquiry

Course Title

*NEW COURSE* Auditing for Data Integrity

Training for QA and Management on implementing effective strategies for internal and external Data Integrity auditing.

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Date

Available upon enquiry

Duration

1 Day

Location

Available upon enquiry

Course Title

Data Integrity for Management

Provides an overview of DI threats and issues for paper/electronic systems. Explains management obligations to resource implement and deliver a DI Governance system compliant to regulation.

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Date

Available upon enquiry

Duration

Half Day

Location

Available upon enquiry

Course Title

Data Integrity for Practitioners

For staff involved with development and implementation of a DI Program. Provides an overview of DI threats and issues within paper/electronic systems. Explains key deliverables/tasks required for a successful DI Program, compliant to regulation.

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Date

Available upon enquiry

Duration

Full or Half Day

Location

Available upon enquiry

Course Title

Data Integrity for Operational Staff

Explore the roles and responsibilities of operational staff taking on roles such as Process Owner, Data Owner, Data Custodian, System Owner, Data Steward, Data User, in order to comply with regulatory requirements.

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Date

Available upon enquiry

Duration

Full or Half Day

Location

Available upon enquiry

Course Title

Online Data Integrity Training

Aimed at organisations, new starters and existing staff, as part of the ongoing DI training. The course provides an overview of DI threats and issues posed within paper/electronic systems and how to comply with regulatory requirements and expectations.

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Date

Available upon enquiry

Duration

20 minutes - access for 2 months

Location

Available upon enquiry

Course Title

Bespoke Data Integrity Training Courses

Our courses come as standard modules, but we can customise the courses to meet your specific requirements. This could include, more practical exercises, based on your organisation and its challenges, along with discussions based on your companies equipment.

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Date

Available upon enquiry

Duration

Course Specific

Location

Available upon enquiry

Get in touch

Discover how we can help your organisation.

Send a message

+44 (0)1633 400939

+44 (0)7735 204233

Data Integrity

Do you have concerns regarding Data Integrity? We would be delighted to have a chat with you and help you leverage our expertise, knowledge and skills.

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Computer Systems Validation (CSV)

Validation of Computer Systems is an on going challenge for the regulated industries. Many businesses lack the knowledge, skills and resources to meet the demands that Computer System Validation poses.

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Training

Within the Pharmaceutical, Biotech, R&D, Blood, Medical Device and regulated industries training is an absolute requirement. Each organisation must be able to demonstrate the competency of its staff to deliver their roles.

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Why Choose Clarity?

Delivering Tailored Solutions

With an integrated risk based approach to Data Integrity, we can deliver a tailored solution to ensure you achieve Data Integrity compliance - by benchmarking your current position, training your team, helping you implement a governance system and supporting you through assessments to remediation and ongoing operational Data Integrity compliance.

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Data Integrity Training

Will be recommending to others, especially IT!

I have come away with a good level of understanding and list of actions required to put a Data Integrity plan in to action and review globally. Very useful course.

Global Quality Compliance Manager.
Online Data Integrity Training

Making training simple

"The online course is ideal for our requirements and vastly simplifies the scheduling and delivery of essential training to all of our team including shift workers - which otherwise is a logistical nightmare".

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Clarity's support and drive has taken a huge weight off my shoulders

"I would strongly recommend Clarity Compliance Solutions for all aspects of Data Integrity. Clarity have set up and lead our Data Integrity program, delivering excellent training to our management and program teams and setting up our DI governance systems, project managing and leading our assessments, setting up our risk assessment and remediation processes. I would strongly recommend Clarity for Data Integrity, CSV and Quality Systems compliance".

Quality Director.

Contract Manufacturer
Data Integrity Training

Excellent course - good pace and mix of presentation and discussion, in a friendly manner

The Data Integrity training course has given me a more detailed regulatory knowledge and guidance on what to consider to ensure the implementation of a robust DI program. I will now ensure that DI monitoring is implemented and built in to our internal audit program and that DI for computer systems is considered in the design qualification of instruments.

QA Executive.
In-House Data Integrity Training

Bringing 'Clarity' to Data Integrity

“David worked with senior management and key operational staff bringing a focus to the increased requirements with regard to data integrity. He presented a series of interactive training modules which were very well received and enabled staff to fully understand how we as a business need to further develop our systems. All feedback from the training was very positive. Ultimately our processes and procedures satisfactorily met the MHRA expectations during our recent audit. Personally I found David easy to work with and I would highly recommend him as somebody who could bring knowledge and clarity to the area of data integrity”.

Ashley Brierley, Quality and Regulatory Director.

Thornton Ross