Billy Miller

Background

About Billy Miller

Founder and currently the President of Lotus Consulting Group, Inc, a Validation and Regulatory Compliance company providing contract services to the regulated pharmaceutical and biotechnology industries. · Experienced project and human resource manager with both large and small capital projects as well as “in house” projects related to validation and regulatory compliance activities. · Over 12 years experience in the pharmaceutical and biotechnology industries specializing in validation and regulatory compliance. · Solid understanding of multiple aspects of validation including process, process equipment, software automation, sterilization, cleaning, facilities/utilities, and controlled environments. · US 21 CFR Parts 210, 211, and Part 11 regulations, EU/EC regulations, cGMP, GAMP4, Change Control, GAP Analysis, SDLC Systems, etc. · Strong knowledge and practical experience in processes, technologies, and process equipment. · Very strong technical writing skills; highly knowledgeable of best practices in validation and manufacturing documentation. · Effective computer applications and presentation skills. · Excellent analytical and problem solving skills. · Outstanding leadership skills; consistently a key contributor and high performer. · Strong people skills, highly versatile, flexible, and well balanced. · Outstanding communication skills, both oral and written.