Results-driven and tenacious Training Systems Remediation Leader with a proven track record of aligning and maximizing people, process, and systems with strategic business vision, and establishing a foundation of GXP quality as a corporate lifestyle in the mitigation of regulatory compliance issues or risk. How do I do this? By collaborating with executive leadership, cross-functional leaders, and team members to assess, develop, harmonize and execute the strategic and tactical initiatives that achieve your organizational and/or compliance objectives. By building solid relationships across all levels of the organization and influencing individuals and groups to positive, empowered action.By utilizing my expertise in managing large scale projects, technical knowledge in the development of efficient, user-friendly systems, remediation of training-related compliance issues, and ability to motivate and drive behavioral change.By developing and implementing systems that assess training effectiveness at both the operator and system levels. By providing engaging and interactive training in the development of GMP awareness, Good Documentation Practices, and writing effective SOPs.By using my years of experience in Human Resources to help my clients assess job competencies, and develop job descriptions and curricula that align with the qualities of top performers. While the majority of my clients have been regulated manufacturing organizations, I welcome inquiries from any organization looking to revitalize their systems, processes, and people.Partial Client ListAlpharmaMylan PharmaceuticalsMylan TechnologiesTeva Animal HealthLachman Consulting ServicesSEO Keywords: GMP training programs, Good Manufacturing Practices, 21 CFR Part 211,111, FDA, Consent Decree, Warning Letter, curriculum development, quality systems, good documentation practices, SOP, instructional design, procedure, audit, pharmaceutical, biotech, dietary supplements.Specialties: GMP Training System Evaluation, Design and ImplementationConsent Decree RemediationCurricula DevelopmentDocumentation Systems & DesignOperational ProceduresInspection ReadinessGMP TrainingGood Documentation Practices TrainingSkill Building for TrainersBehavioral Interviewing Behavioral Assessments - PDPLeadership DevelopmentTransition Coach