Dr.Thurloch O'Criodain

Dr.Thurloch O’Criodain is a Senior Quality Leader with 40 years’ experience spanning medical devices, pharmaceutical and biopharmaceutical quality operations.

Thurloch has worked for some of the world’s leading companies including Abbott Laboratories, Wyeth, Johnson & Johnson, and Novartis Pharma AG. His experience includes working at both local and corporate levels.

Thurloch served as the Regional Director of Quality for the EMEA region at Wyeth. While in this role, he managed 9 new product launches at European level. He also served as International Director of Compliance Auditing at Wyeth. In Novartis, Thurloch was responsible for quality operations across 14 drug product manufacturing sites. Thurloch went on to lead a number of international compliance remediation and improvement projects. He has successfully managed the preparation and execution of more than 20 FDA inspections in the last five years, of which 8 were pre-approval inspections leading to successful product launches.

Since leaving Novartis, Thurloch has been working independently to provide training and consultancy services to the pharmaceutical industry, working on three continents and with several different companies and organisations.

Thurloch has earned a Ph.D. from the National University of Ireland, as well as a post-graduate diploma in pharmaceutical manufacturing technology, which qualifies him to work as a Qualified Person in accordance with European regulations. He is a senior member of the American Society for Quality, and a member of the Parenteral Drug Association.

Key competencies include cGMP, Quality Assurance/Systems/Control, Compliance, International Product Transfer, Regulatory Strategy, Remediation Leadership, Special Process Validation, Validation Planning, ISO 9001 and ISO 13485

Danielle DeLucy

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance.

Prior to this role, Danielle has been in the industry for 20 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.

Danielle has held positions in the Quality management arena while increasing her responsibility through these years. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process prior to any inspection.

Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

J. Carlos García González

J. Carlos García González, is a Quality Expert with over 20 years Wide expertise in Failure Investigations, Inspection Readiness, Lean Management and other Quality Management aspects.
He is also an connoisseur in Compliance and Inspections both FDA and EMA regulations, and other regulatory agencies around the World (ANVISA, KFDA, Turkish MoH, etc)
A Strong leader creating cohesiveness within teams, J. Carlos’ motivational skills drives results in team performance above individual ability levels, consistently surpassing customer expectations.
J. Carlos is an innovative thinker, consistently pursuing new challenges to stretch abilities, expand knowledge and bring greater returns to Clients.
His mantra ‘Quality that Sums’ is directed towards assuring collaborative efforts for continuous improvement strategies and initiatives for the Organizations, to result in successful Quality Systems.

Uzma Aitqad

Ms. Uzma Aitqad is an Organizational Change and Culture Design specialist with over 24 years of experience in Transformational Change Consulting, Leadership and Management, driving changes with embedding fit for purpose cultures Globally.
Her approach to consulting is significantly underpinned by academic and industry-led research insights and frameworks.
She has been helping businesses face transformational change and cultural alignment challenges, with the transformational change methodology and culture assessment & culture fitness toolkit that she developed with great success.
She has also been lecturing as a visiting faculty in the Brighton University, Business School & mentors International Leadership Development, Organization Development and Culture Change, working across Cultures and Emotional and Cultural Intelligence.