EPIC – Efficiency, Process Improvement and Compliance
EPIC Consultancy and Training Ltd is a consultancy based organisation headed up by Mark Thompson and Gavin Ross. This new company is born out of an understanding of the current needs of the Pharmaceutical, Biotech and Medical Device industries! Today’s issues, and opportunities.
Efficiency, Process Improvement and Compliance
Gavin and Mark have a wealth of knowledge and experiences to draw upon. Over the past 22 years they have worked all over the world with hundreds of organisations, delivering training to thousands of people, including regulatory bodies and regulatory inspectors.
EPIC‘s real strength is in the Application of this knowledge. Today information is readily available via the internet, webinars, etc. There is information overload in many areas. Intelligent application of knowledge and experience to specific site and/or product requirements is what delivers the most Efficient Process Improvements and Compliance.
Scroll through all Projects & Updates
Technology and Process Specific Training
May 16, 2012Objective Develop a course tailored specifically to the needs of the site (technology, process and product specific). The Course is to be used as a benchmark level of training to ensure all site personal gain the same level of knowledge, in the most cost effective and efficient way Deliverables Unique training modules that were develo...
Read moreDevelopment of bespoke training structure
May 16, 2012Objective To develop and define a new approach to the structure and implementation of training at a client site Deliverables Site training matrix and training policy Documented training structure, identifying the different levels of education and learning outcomes along with the required assessment at each stage Unique training pa...
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HACCP Evaluation
May 16, 2012Objective To evaluate the likelihood of bio burden contamination within the process stages Deliverables HACCP study looking at all process stages from Raw material delivery through to finished product storage in the controlled warehouse Executive summary findings, detailed report a...
Read moreSubject Matter Expert Support
May 16, 2012Objective To provide support as a Subject Matter Expert (SME) relating to the sterilisation and bio-burden control processes on site Deliverables Monthly visits to site to: Review Change Controls, Manufacturing Documentation, Batch Records, and Deviations Assist in any troubleshooting exercises Deliver one to one coaching and tr...
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Process Transfer Project
May 16, 2012Objective To support and help define the requirements to enable the transfer of a sterile product to an alternate manufacturing facility Deliverables Site Monographs for sterilisation Processes Operations, Maintenance and testing procedures Site Protocols for Qualification and Re...
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Critical Alarm Testing
May 16, 2012Objective Risk Assessment of Critical Alarms, to evaluate the necessity and requirement for routine testing Deliverables Risk Assessment for all critical alarms defined at the client site Assessment summary document explaining the rationale behind each decision (Example evaluation ...
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Site Calibration Strategy
May 16, 2012Objective Audit and develop the site calibration system in line with current cGMP expectations Deliverables Site Calibration Monographs and associated SOP’s, Instrument database, which included, descriptions, loop elements, process tolerances, loop accuracies, calibration set poi...
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Disaster Recovery Policy & Documents
May 16, 2012Objective To generate the site disaster recovery policy and associated documentation Deliverables Works included the development of site policies that defined the scope and scenarios that had been considered and evaluated. Beneath these were the detailed recovery procedures t...
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Great North Run
May 15, 2012Once again Gavin and Mark are going to drag each other around the Great North Run on Sunday 16th September 2012 for each of their chosen charities. As a business we will be supporting these charities once again (as long as our knees hold out) and thank you for all your support th...
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