Allan Marinelli

Allan Marinelli is currently the President of Quality Validation 360 Incorporated and has acquired over 24 years of experience (Well Balanced experience between Quality Assurance/Quality Systems and Validation) within the (Bio)-Pharmaceutical, Medical Devices (Class 3), Vaccines, and Food/Beverage industries. His cGMP experience has cultivated expertise in quality assurance, compliance, quality systems, quality engineering, remediation’s and validation roles controlled under FDA , EMA and international regulations (WHO, KFDA, SFDA etc). His experience includes, but is not limited to: quality systems, CAPA coaching, remediation’s, QA change control coaching , QA deviation coaching, equipment validation (Writing, executing, and finalizing reports to completion), process validation, computer validation/GAMP 5, cleaning validation, quality assurance management, project management, and strategies using the ASTM-E2500-07, and ICH Q9 approaches.

Allan Marinelli has lead numerous clients in regulatory audit preparedness, consent decree/remediation experience and has defended many clients in front of the FDA to assist in licensure of their facilities (BLA, NDA etc). Moreover, he has worked and lived overseas at client sites in Belgium, France, South Korea, China, India and Canada. He has written 38 peer reviewed publications from scientific articles and chapters (1 pending chapter in a PDA book) to Management oriented articles. Allan attracts an audience from the medical devices, pharmaceutical, biopharmaceutical, and vaccine industries.

One of Allan's recent publications includes:

(1) “Quality Risk Management Sampling Plan-A Validation Engineering Perspective” in a Parenteral Drug Association (PDA) book Environmental Monitoring Volume 7 edited by Jeanne Moldenhauer published in 1st quarter of 2015.

You can read more about him and his work on Life Science Leader, Pharmaceutical Online, Outsourced Pharma, and Bio Process Online.

In addition, Allan has contributed as an Examine Item Writer Subject Matter Expert in the International Society for Pharmaceutical Engineering (ISPE) Professional Commissioning (PCC) in 2011, and has contributed to ISPE Baseline GAMP and Engineering Manuals (for example, ISPE GAMP Good Practice Guide: A Risk Based Approach to IT Infrastructure Control and Compliance June 2015; Baseline Guide Oral Solid Dosage, Third Edition 2014, PQLI, Design Space, Regulated Mobile Application; ISPE Good Practice Guide: Sustainability-2014; ISPE Good Practice Guide: Product Quality Lifecycle Implementation, Control Strategy.