Bio
Lori Wright, President & Founder.Serving the Complete FDA-Regulated Supply Chain. ECL2 Consulting Service LLC (ECL2) an 8(a) certified company, assists primarily organizations regulated by the FDA. Lori has twelve years of successfully building new programs while in leadership roles. The majority of her career has been focused in the complete supply chain industry ranging from light manufacturing to the end user.
Prior to creating her consulting business ECL2, Lori Wright's combination of operational, quality assurance and regulatory experience has positioned her as a leader in this field. Lori has further set herself apart from her peers by becoming a “Change Agent”, facilitating cross-divisional optimization projects, all phases of strategic planning and coalition formation.
Lori Wright is a subject matter expert on FDA, DEA and State regulation, having established the UPS Supply Chain Solution Healthcare Division’s national quality and regulatory program and serving as the SME for the UPS Corporate Compliance board to determine the strategic direction for the company. In this capacity, the company served as a 3PL, Lori worked with over sixty large pharmaceutical and medical device companies including Cordis, Endo Pharmaceuticals, Abbott Labs and numerous others to ensure that UPS met regulatory requirements on behalf of each one of these organizations. In addition to her focus on healthcare, because of her solid foundation in FDA law, Lori was also active in overseeing facilities pursuing food storage and becoming familiar with AIB standards.
In Lori Wright's manufacturing experience, she has been involved with creating operations from the ground-up. All of these operations were established in compliance with the FDA’s Good Manufacturing Practices. These start-ups included working with general contractors to build-out the facility, establishing flow of materials, creating procedures, developing programs including internal auditing, sanitation, pest control, corrective and preventative action (CAPA), complaint handling, management reviews, supplier approvals, etc.. Lori has provided turn-key services for her clients since establishing her consulting practice. She has also guided companies in pursuing ISO certification and obtaining the CE Mark in order to ship internationally.
Lori Wright's manufacturing experience combined with her in-depth regulatory knowledge including FDA, DEA and State requirements, set the stage for her role with Sisters of Mercy Health System to increase patient safety through re-engineering medication delivery. She was a key player in overseeing components of the design and construction phase of the distribution center and repackaging operation. This newly created infrastructure was integrated with system applications as well as proceduralized process to support operations. These efforts satisfied the numerous and complex regulatory requirements, successfully achieving licensure for an entity not fitting any previous organizational model. While at Mercy, Lori also worked with the GPO to develop standard operating procedures. Lori’s expertise was requested by member hospitals, providing leadership in finding solutions to operational problems and implementing applications.
Lori has thirteen years of experience with military logistics, both in an active duty and reserve capacity. Her efforts while serving in the role of an element commander for the food, fuel and water missions supporting humanitarian relief mission in Guatemala won her praise as well as formal recognition from the army. She was honorably discharged as a Captain within the Medical Service area. Prior to her commission as a Medical Services Officer, Lori held an army commission in the QuarterMaster corps.
Lori Wright graduated from the University of Maine with a bachelor’s degree in business and pursued graduate studies at Temple University. Lori’s studies included such courses as Food & Drug Law, Good Manufacturing Practices, and Computerized System Validation. She also holds a Master’s certificate in Project Management through Villanova University. She has been trained as a Six Sigma Black Belt through the American Society for Quality and is a trained facilitator.
ECL2 has provided significant experience and knowledge that has been instrumental to the continued improvement in our supply chain management services. - Taylor White, Vice President, Business Development, VHA, Inc.