Valerie Mulholland

Senior Director / Principle Consultant, GMP Services Ltd

Following 15 years in the biopharmaceutical industry – on a full suite campus of upstream & downstream biomanufacturing and aseptic filling – she launched a consultancy service in 1997. For over 20 years she has provided Regulatory and Compliance Intelligence, including training & auditing services to the biopharmaceutical, pharmaceutical, medical device and blood transfusion industries. She has acted as Lead Auditor across a range of manufacturing technologies, suppliers, distributors, and service providers to EU, FDA and International requirements.

As a qualified microbiologist, she is comfortable auditing a large range of topics, including quality management systems, quality risk management, data integrity, laboratory controls & analytical methods, microbiology, sterilization, validation, computer system validation, quality improvement projects, and design. She is experienced in pre-PAI and regulatory audit assessment – including MDSAP, Technical File & DHF Assessments and audit coaching & training. she is certified as a Lead Auditor to ISO 13485:2016, ISO 9001: 2015 and MDSAP. She will assure you if you are ready for these or any other regulatory audit.

She is secretary of the Irish Chapter of the PDA and have been committed to the organization and moderation of PDA events for many years. As a result, she has extensively networked with regulators and industry experts in emerging or topical areas of interest across the biomanufacturing industry. She participates in the PDA Interest Group on Quality Systems.

She is currently researching a PhD in ‘Demonstrating the Effectiveness of Quality Risk Management in the Pharmaceutical Quality System’ and am honored to be mentored by industry leaders on this topic. Her current focus of research is risk based decision making. She is passionate about Risk Management as a broader control strategy. Co-Host the Risk Revolution Podcast with @Journal of Validation Technology.