cGMP & PROJECT MANAGEMENT TRAINING
MEDVACON offers training in the area of cGMP compliance, Project Management and will custom tailor 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, establishing 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 need we are happy to customize a program that fits your organizations needs.
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, establishing 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 need we are happy to customize a program that fits your organizations needs.
- 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 are two full days of classroom training designed to teach Project Managers and Team Members how to effectively manage projects. Through a combination of lecture and real-life Pacira project workshops, the participants will learn how to effectively plan and execute projects, run efficient status meetings, deal with authority issues and people management, deal with project problems and manage change control. This class is workshop-intensive where the students will be broken up into groups of 4 - 6 and will spend the two days using the tools they learn to progressively elaborate one of their real projects from scope to objective, charter to Work Breakdown Structure, Responsibility Matrix to Schedule and Budget until they have the entire project in their hands. We use large charts and wet-erase markers to ensure the entire team is involved in the workshops. Questions and discussions are encouraged. Our instructor involves everyone in the class through his use of stories and examples, bringing the lessons to life in an entertaining, humorous and, ultimately, lasting fashion. You will walk out of class with the tools you need to plan and execute your projects with efficiency and confidence.
- Rapid Project Startups are one to two day events where the entire project team is assembled and the project is run through the planning phase while being facilitated by the instructor. This is an excellent way to reinforce the training received in the above two courses while giving key projects a head-start toward completion. The instructor will lead the team through the steps of Background, Objective, Scope, Work Breakdown Structure, Responsibility Matrix, Schedule and Budget to arrive at a fully developed plan in one or two days depending upon the size of the project.
- Prioritization Sessions are an assembly of the Steering Committee during which the business unit’s projects are Inventoried, Categorized, Prioritized within categories, then Prioritized across categories to arrive at a single, prioritized list of projects according to business importance. Future Prioritization Sessions eliminate completed projects, prioritize newly authorized projects, reprioritize the list and spend leftover time reviewing projects going through phase gates and projects that have been working without reviews for too long.
- A Project Management Guide is a document customized by a team of client employees assisted by the instructor based on templates he provided that defines the methodology used to manage projects. This becomes the reference guide for those who are tasked as Project Managers and Team Members by delineating their roles, laying out the templates they will be using, explaining the approval and gating processes, showing how resourcing projects works and defining the roles played by all team members in the successful completion of the project. 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.
Example Projects
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Project Management Training - Pharmaceutical
A Pharmaceutical company identified the need for support in developing their internal project management organization in order to support ongoing efficient and effective operation of project teams. MEDVACON delivered the Executive Briefing, the Two-Day Project Management Training session on the East and West Coast, and conducted several Rapid Project Startups. The client was delighted and has scheduled additional Rapid Project Startups at another of their sites.
cGMP/Compliance Training - API Manufacturer
During MEDVACON's on-site CSV initiative the client identified the need for 3rd party Compliance training assistance of operational and administrative personnel; this to increase staff awareness of quality assurance and compliance standards in a GMP environment. Subsequent discussions with the Quality Mgr identified a continued goal of the client maintaining a strong GMP-compliant organization via Compliance training course(s). This training provided Quality, Production, Maintenance, Operational and other personnel, (who possess varying levels of knowledge and experience); the opportunity to refresh and expand their knowledge and applied skills using an in-depth and compliant applicable approach in a GMP manufacturing facility. The Training Program was an immersive on-site engagement.
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cGMP/Compliance Training - CMO
Following a 3rd party audit conducted on-site MEDVACON the CMO's Associate Director of Quality requested additional training support of staff to increase awareness of quality assurance and compliance standards: “As part of the company’s continuing education and commitment to excellence, the CMO has identified a need for Compliance Training of the Quality Team with a continued goal of maintaining a strong GMP-compliant organization via a training course for QA Compliance. This training is intended to provide QA Auditors and QA Management who have basic auditing knowledge and experience, the opportunity to refresh and expand their knowledge and applied skills using an in-depth and compliant applicable approach in a GMP CMO manufacturing facility.” “In a fast-paced, multiple-shift, versatile work environment, the overarching goal is to raise the proficiency and efficiency level of QA Auditors from passive, by-the-book checking of documentation / documents to an interactive and supportive Quality Department that can quickly evaluate issues or gaps, offer compliance guidance / recommendations/instructions with confidence while focusing on solutions that direct the work activities as needed to achieve work schedules, project tasks and meet business timelines, without compromise on compliance.” Consequently; MEDVACON developed and delivered the onsite two-day Training Program as an immersive engagement at the CMO facility.
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