Consulting

Project Support

It is quite common for projects to generate staffing requirements beyond the normal personnel numbers and skillsets of an organisation.

The principal consultant at TOC Consulting, Dr. Thurloch O’Criodain, has the qualifications, experience and background to support such projects as :

Design, commissioning and qualification of new facilities or facility expansion
New product launches
Product lifecycle management

We will be happy to look at your project needs and see how we can help you.

Inspection Management and Remediation

Inspections are a fact of life in the pharmaceutical industry, and in recent years the number of health authorities carrying out inspections has increased significantly.

In this environment, every inspection creates a risk. A bad inspection outcome can and does lead to loss of sales as well as costly remediation programs.

Even when your Quality System is essentially compliant and conforming to standards, it is all too common for inspections to go wrong.

Failures in preparation and organisation, as well as failures in communication and presentation of the quality system are the most common reasons.

TOC Consulting can help you avoid those risks by optimizing your preparation for health authority inspections. We can also help by supporting your staff through the inspection, and if necessary in preparing and submitting the response to any observations received.

Quality System Development

Is your Quality System compliant with GMP and meeting the standards required by the regulators?

TOC Consulting can help to answer that question, and also to prepare and implement any changes that may be required.

The “c” in cGMP means “current”, and TOC consulting can provide the support to help you to make sure that you continue to be compliant, even in a world of increasing complexity and changing requirements.

Quality Organisation Design and Deployment

In almost any business, success depends about 90% on people and 10% on technology and operations.

Therefore it makes sense to make sure that you have the right people, deployed in the best way to get the best results.

TOC Consulting can support you in this effort, from organisational assessments to redesign of your existing organisation.

Batch Disposition and Deviation Management

The principal consultant at TOC Consulting, Dr. Thurloch O’Criodain has worked as a QP for many years.

This allows him to review and support the decision making process for problem batches, providing advice and guidance on what is acceptable and what is not.

He can also give direction in relation to the preparation and organisation of supporting documentation.