Valerie Mulholland GMP Services

Valerie Mulholland is the Principal Consultant at GMP Services, Ireland. For over 20 years, she has provided Regulatory and Compliance Intelligence, including training and auditing services to the biopharmaceutical, pharmaceutical, medical device and blood transfusion industries. She is a Lead Auditor across a range of manufacturing technologies, suppliers, distributors, and service providers to EU, FDA, and International requirements. She also provides audit coaching & training. She is a researcher with the Pharmaceutical Regulatory Science Team (PRST) in TU Dublin. The PRST actively engages with global industry and regulators to address the challenges and opportunities of implementing Science and Risk based approaches. The current research focus of the team includes research on quality risk management (QRM), knowledge management (KM), post-approval change management, quality metrics, and related topics covered by ICH Quality Guidelines. Valerie’s area of research is decision making within QRM and the PQS. She is the current Secretary of the PDA Ireland Chapter.