cGMP & PROJECT MANAGEMENT TRAINING

MEDVACON offers training in cGMP compliance, project management and will customize a compliance course for your organization.

Good Manufacturing Practice regulations, which have the force of law, require that manufacturers, processors, and packagers of medicinal products take proactive steps to ensure that their products are safe, pure, and effective. cGMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. Personnel involved in cGMP must have documented training of current Good Manufacturing Practices (cGMP) training. This webinar will focus on the FDC Act and 21CFR federal regulations as applied to cGMP and provide an overview of the US FDA regulations for compliance.

MEDVACON's ​cGMP course covers the requirements for establishing strong quality management systems, obtaining appropriate quality raw materials, building robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories within a pharmaceutical production environment. Participant involvement is encouraged through the use of practical exercises, quizzes, and examples from actual companies.

MEDVACON's Project Management Training spans a wide variety of areas and if the specific courses below do not fit your needs MEDVACON can easily customize a program that fits your organizations goals. 

• An Executive Briefing consists of a two to four-hour session with the senior staff training them on the importance of Project Management to the organization. They will learn the role they need to play during the Maturation of Project Management, the way to convert high-level strategies to Project Objectives, the methodology of Project Prioritization and the way to effectively run the Phase Gate Sessions.
• Project Management Training sessions occur in two days of classroom instruction designed to teach project managers and team members how to effectively manage projects. Through a combination of lecture and real-life project workshops, participants will learn how to successfully plan and execute projects, run efficient status meetings, address authority issues and project conflicts, and manage change control. This class is workshop-intensive, and students will spend the two days applying their training to progressively elaborate their real projects from scope to objective. Our instructor applied real-life to make instruction entertaining and humorous, ensuring that the attendees will leave class with the tools needed to plan and execute projects with efficiency and confidence.
• Rapid Project Startups are one-to-two-day events providing project planning run through to refresh earlier instruction. The instructor recaps background, objective, scope, work, breakdown structure, responsibility matrix, and budget resulting in a fully developed plan.
• Prioritization Sessions serve to inventory, categorize, and prioritize business unit's projects to reach consolidated project lists according to business importance. Additional prioritization sessions further refine businesses' project lists to keep project scope timely and efficient.
• A Project Management Guide is a template-based document customized by client employees in conjunction with the instructor to define project management methodology. This document serves as the business standard for project managers and team members defining roles, templates, approval and gating process, and resources works to achieve successful deliverables. This guide defines the role of the Project Management Office (PMO) and is maintained in future, along with all templates and the resourcing spreadsheets by the PMO. The templates are provided free along with the acceptance of 10 days of facilitation time in the process of customizing this guide.