Pharmaceutical GMP

Mike Halliday has extensive pharmaceutical manufacturing management and QA experience, gained over 20 years working for three major international pharmaceutical manufacturers. Before joining NSF in 2003, he was Associate Director, Global Audit and Compliance for Wyeth Europa. He was also previously a partner at David Begg Associates (DBA).

Mr. Halliday is eligible to act as a Qualified Person and is an honorary lecturer at the University of Strathclyde.

He has broad experience in the manufacturing management and QA of a wide range of sterile and non-sterile dosage forms and is fully conversant with current EU and FDA GMP regulations and requirements. He has extensive experience in international QA auditing of a wide range of pharmaceutical manufacturers and specialist distributors in Europe, the Middle East, America and Asia Pacific.

Areas of recognized expertise include:

• QP training
• Packaging and labeling control
• GMP legislation
• API manufacture and control
• Auditing and self-inspection skills – Education of auditors
• Supply chain distribution

Samantha Clack is a quality consultant and Qualified Person with over 20 years of experience in technical, quality and managerial roles in parenteral, solid dose and topical dosage form manufacture.  She is an ISO Lead Auditor and also the trainee QP coordinator and secretary for the Pharmaceutical Quality Group (PQG).

She started her career with Patheon Ltd (formerly Hoechst Marion Roussel) in Swindon, where she worked in technical and managerial roles in manufacturing and packaging. With Patheon she gained experience in a wide range of dosage forms including sterile powder filling, sterile and non-sterile ointment filling, creams, liquids and suppository manufacture and filling, tableting and packaging.

She next worked for Eli Lilly & Company Limited as a senior quality assurance associate in the Corporate Quality Assurance division. Her responsibilities included auditing Lilly’s third-party contractors and suppliers covering parenteral, biotech, liquids and creams, solid dose and API dosage forms as well as excipients, warehousing, marketing affiliates and clinical trial sites. The role also involved providing training in quality management systems for Lilly affiliates worldwide.

Ms. Clack then joined Eisai Manufacturing Limited as QA Manager of Marketed Products, concentrating on the start-up of a new solid dose manufacturing and packaging facility, implementing and developing quality systems and processes as well as performing batch disposition activities for products manufactured at contract manufacturers. She played a key role in the management of regulatory inspections, cumulating in the site gaining its full manufacturing license.

Her recognized areas of expertise include :

• Microbiology
• Solid dose and sterile product manufacture and packaging
• Quality management systems
• Qualified Persons training
• Auditing of excipient, API, finished dosage form and primary and secondary packaging facilities worldwide

John McCool has over 15 years of pharmaceutical industry experience and provides auditing, consultancy and training services to manufacturers of biologicals, biotech products and sterile products. He has extensive experience with multiple dosage forms (steriles, biologicals, tablets, capsules, radiopharmaceuticals and investigation medicinal products) and in providing quality, technical and regulatory advice.

Mr. McCool is eligible to act as a QP under the permanent provisions and qualified in 2008. He has particular expertise in sterile manufacturing and the application of GLP, GMP and GCP to the manufacture and control of clinical trial materials.

Mr. McCool spent a number of years working in a range of companies from small virtual, academic institutions to large multinational companies. Earlier in his career, he taught basic and advanced science courses for children and adults to achieve recognised UK qualifications.