- Achieve regulatory approval in North America, Europe and Asia.
- Develop and remediate quality systems to ensure regulatory success.
- Develop facility CQV, and PV strategies for faster, leaner project execution.
- Provide expert guidance on current and leading edge innovative technologies.
- Achieve facility readiness for pre-license/approval Inspections under a smart and compliant program.
- Consolidate ideas into best fit cGMP concept designs with accurate cost benchmarking for informed board decisions.
- Implement operational readiness and lean manufacturing strategies to reduce COGs.
- Get a solid foundation for strategic decisions on matters regarding supply chain, manufacturing, technology choices, and regulatory matters.
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Meet the team
Sue is a Principal Biopharma Consultant and Managing Director of the DPS Global Strategic Consulting Group. Sue has over 25 years’ experience in the Biopharmaceutical sector in Ireland, UK, mainland Europe and USA engaged in Consultancy, Project and Program Management. Sue has a depth of experience in the early phase development of Biopharma projects leading feasibility and concept design studies for new facilities as well as extensive experience managing full design and construction project implementation. Her experience covers a broad range of facilities from laboratories, development and manufacturing facility projects in the drug substance and drug product areas, primarily for Biologics and ATMPs.
Dr. Aidan Harrington, BSc.Micro., PhD. Molec.Biol., DPS Principal Consultant, has been working in the Pharmaceutical Industry since 1992. Aidan has worked in QA, Validation and Engineering roles in manufacturing and capital project environments for the pharmaceutical industry and is an expert in US FDA and EU cGMP regulations. He has extensive regulatory inspection exposure experience, both FDA and EMA and participates in facility readiness programs for a wide range of clients, in traditional biologics, advanced therapeutics (ATMPs) and aseptic filling.
Aidan has played significant roles on the planning and implementation of CQV programs for large capital projects including implementation of Quality Risk Management principles from concept design phases to PV/PPQ. Aidan provides consultancy in areas such as cGMP compliance, risk assessments, technology transfers, CDMO audits, pre-inspection readiness audits, CQV and quality program strategies and quality remediation. Aidan’s experience covers all aspects of biologics including cell and gene therapy advanced therapeutics, (ATMPs), drug substance and drug product, aseptic filling. He is a on the PDA SIG for the BSR PDA Standard 03-201x, Standard Practice for Quality Risk Management of Aseptic Processes.
William (Bill) Whitford is the Life Science Strategic Solutions Leader for DPS Group Strategic Consulting Team, supporting innovative therapeutics and developing life science solutions. Bill’s experience includes R&D Leader, developing and commercializing over 40 distinct products supporting diverse biomedical and biomanufacturing applications, including products supporting protein and vaccine production in mammalian and invertebrate cell lines.
An invited lecturer at international conferences, Bill has published over 300 articles, book chapters and patents in the bioproduction arena. He now enjoys serving on such boards and committees as the Editorial Advisory Board of BioProcess International. His recent publications involve processes and facilities supporting sustainable biomanufacturing, Industry 4.0 and digitalization, bioreactor model-based prediction and control, bioprocess intensification, continuous biomanufacturing, cell and gene therapy applications, exosome production and isolation, 3D bioprinting, theranostics, and biointelligent manufacturing.