The Center for Professional Innovation & Education, Berlin, Germany
03/27/08
Who Should Attend
This two-day course is designed for those who perform, supervise, manage, audit, or oversee maintenance management in a pharmaceutical GMP environment. This includes, but is not limited to, Maintenance Managers, Quality Managers, Production Managers and Chief Engineers. The course will also benefit those in other departments who find maintenance management among their responsibilities.
Learning Objectives
Upon completion of this course, attendees will have a clear understanding of the relationship between Good Manufacturing Practices and the development, implementation and execution of a maintenance program in the pharmaceutical environment. During the course, all relevant GMP procedures will be discussed and participants will execute system criticality assessments and system maturity assessments. Attendees will learn how system maturity forms the basis of competence management. They will understand how knowledge, skill, attitude and the fulfillment of responsibilities form the key to compliance and successfully passing inspections and GMP audits. Participants will gain practical experience in using the “balanced score card” to create both a GMP baseline maintenance management protocol, as well as, a value-driven continuous improvement strategy focusing on maintenance excellence. In addition, the importance of alignment with business strategy will be highlighted. The complete picture of physical asset management and the equipment lifecycle will be detailed, covering project management, operations/first line maintenance and Total Productive Maintenance (TPM).
Course Description
This course incorporates theory and workshops to provide practical expertise, and “peer supervision” sessions to obtain feedback on one’s own performance and management skills. Peer supervision is also used to benchmark the quality and completeness of the attendee’s maintenance management ideas against those of their colleagues. An interactive overview of common pitfalls, constraints and bottlenecks will encourage participants to think critically through discussion. Additionally, attendees will be given the opportunity to discuss what they feel should be included in the scope of a pharmaceutical maintenance program.
A workshop to define maintenance management strategies and continuous improvement protocol will be conducted using the “balanced score card.” In addition, there will be ample time to address specific problems and questions of individual participants.
After completing this training course, you are able to: - Understand the GMP baseline for maintenance
- Determine system maturity levels
- Set up a maintenance management strategy/master plan
- Draft relevant Standard Operating Procedures (SOP’s)
- Expand your influence through playing a pro-active role in physical asset management
- Bring continuous improvement projects in practice
- Focus on excellence
- Understand competence management
- Train your organization
Additional benefits of this class include:- All participants receive a syllabus with: examples, templates and more
- Participants will have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 20 years of industry experience
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