As regulations and business operations adapt, so too must the QMS. It is never as simple as just slotting in some quick fixes that mimic the wording in the revised regulations or doing the bare minimum to meet the needs of the new operation.
Instead, he explains the advantages and introduces tools for a thorough gap analysis each time there is a significant change to review the QMS against the new regulation or commercial process. It ensures that the benefits and risks of every operation and process explained in the revised QMS are weighed and adequately assessed. It also allows the company to tabulate all the gaps, get a holistic overview of the resource needs, and make informed choices with the senior management teams.
Managing Director & Consultant QP / RP
Charley is the owner and Managing Director of Orion GXP Consulting. He has over 20 years of experience working in manufacturing QA, regulatory compliance, batch release, and distribution in the pharmaceutical and medical device industry. He has assisted multiple clients with designing, developing, and implementing phase-appropriate Quality Management Systems, vendor management, audit programs, quality risk management, and training. Charley has a Bachelor of Science In Biochemistry and a Master’s In Pharmaceutical Manufacturing Technology. He has acted as a QP in Ireland for sterile and non-sterile manufacture, clinical IMP release, and third-country Importation.