Robert Haslam
Robert Haslam
Robert Haslam, Managing Director, Somerset House Consultants has over forty years of experience in Quality Assurance, Production, Development, Clinical Trials and Regulatory Affairs gained in multinational and start-up companies. He is the Managing Director of a consultancy providing quality assurance, manufacturing, development and training support to pharmaceutical companies worldwide. He is an EU ‘Qualified Person’ for marketed and investigational products, including steriles and non-steriles, generics, biopharmaceuticals, herbals. He is also an ISO-qualified Lead Auditor; experienced in EU & FDA Good Manufacturing Practice.
He has extensive experience in GMP audits of drug substance, drug product and Investigational Medicinal Product manufacturers; outsourced activities; supply chain risk management. He has a successful track record of strategic management, facility qualification, designing and implementing quality systems, managing quality remediation programs, product development and outsourcing. He has designed and delivered bespoke GMP training courses to companies worldwide. Expert witness in litigation involving GMP compliance.
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EU and US GMP/GDP – Similarities and Differences
Compliance with GMP and GDP regulations is essential for medicinal product development, manufacturing and distribution companies. Despite the recent Memorandum of Understanding between FDA and EMA, the two major regulatory bodies have different legal structures, functions and regulatory emphasis.... -
Data Integrity in the Pharmaceutical Industry
Data integrity is essential to regulatory compliance within the pharmaceutical industry. MHRA, FDA and WHO have all issued guidances on data governance, and assurance of data integrity forms a key part of regulatory inspections. Recent Warning Letters to pharmaceutical... -
Data Integrity in the Pharmaceutical Industry
Data integrity is essential to regulatory compliance within the pharmaceutical industry. MHRA, FDA and WHO have all issued guidances on data governance, and assurance of data integrity forms a key part of regulatory inspections. Recent Warning Letters to pharmaceutical... -
Annex 1 Manufacture of Sterile Medicinal Products
Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products, particularly in the manufacture of sterile medicinal products. Major changes have recently been made to the EU GMP guideline covering manufacture... -
EU and US GMP/GDP – Similarities and Differences
Compliance with GMP and GDP regulations is essential for medicinal product development, manufacturing and distribution companies. Despite the recent Memorandum of Understanding between FDA and EMA, the two major regulatory bodies have different legal structures, functions and regulatory emphasis.... -
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