We are pleased to announce that Lori-Ann Woodard has accepted the position of Director, Medical Device at Lachman Consultants, effective August 20, 2018.
Ms. Woodard delivers expertise in the implementation and management of Quality Management Systems for medical devices, Software as a Medical Device (SaMD), and combination products. She has more than 20 years of experience that includes building QMS and cGMP quality systems from the ground up, and combination product development and manufacturing operations. She is an expert with extensive knowledge and application of the Code of Federal Regulations and international standards in the Medical Device, Combination Product, and Pharmaceutical industries; as well as applied knowledge of FDA Mobile Medical Applications Guidelines. Earlier this year she was a speaker for the SaMD Software Design for Medical Devices Global 2018 Munich, Germany on Connected Combination Products.
Prior to joining Lachman Consultants, Ms. Woodard served as Associate Director of Quality Compliance Combination Products at Teva Pharmaceuticals for the past four years. Prior to joining Teva, she served as Director of Quality at Medtronic (TYRX, Inc.); Manager of International Quality Systems at Instrumentation Laboratory, Inc.; and Senior Manager, Quality Control Inspection at Eli Lilly (formerly known as Imclone Systems). Earlier experience includes Senior Quality Engineer/Manufacturing Manager at Ortec International; QA Supervisor at both Genzyme Biosurgery and at Johnson & Johnson (Cordis). She has also served as an independent litigation consultant / expert witness.
Ms. Woodard earned her B.S. in Electrical Engineering from Cornell University, New York. She is ASQ Certified in Software Quality Engineering; Quality Engineering; and Biomedical auditing. She also has a Six Sigma Green Belt certification.
For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.
