Upon completion of this course, attendees will have a clear understanding of the relation between Good Manufacturing Practices and the development, implementation and execution of the maintenance program in a pharmaceutical and medical device environment. During the course, all relevant GMP procedures will be discussed and participants will execute system criticality assessments.
Attendees will learn how maintenance departments can be managed according to the quality system approach and will practice in executing system maturity assessments. Additionally, participants will learn how competence management; knowledge, skills and attitude and the fulfillment of responsibilities form the key to compliance and being successful in passing inspections and GMP audits.
Participants will gain practical experience in using the “balanced score card” to create both a GMP baseline maintenance management strategy, 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, autonomous maintenance and Total Productive Maintenance (TPM).
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
- Manage the system maturity
- Set up a maintenance management strategy/master plan
- Expand your influence through playing an active role in pharmaceutical 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
