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 18 publications, covering topics from Engineering to Management, such as:

(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,

(2) “Procedure for Spray Coverage Testing with Riboflavin” in a PDA book Cleaning and Cleaning Validation Volume 2, edited by Dr.Paul Pluta 2013 (Both published in DHI and PDA) He also published numerous articles in Institute of Validation Technology (IVT) and American Society for Quality (ASQ) respectively as indicated below

(1) “A Workable Sampling Plan Using Quality Risk Management Approach Relative to the PQ Phase Of The Upgraded Water Generation System at the Pilot Plant/Small Scale Level-A Validation Engineering Perspective” published in the Journal of Validation 3rd quarter 2014.

(2) “Against The Grain, Standing your ground when senior majority rules” published in the American Society for Quality (ASQ) 2014.

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 (e.g..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 etc).