Experience shows - the technical implementation of GMP measures is well mastered to a great extent. Solutions are quickly found even in more demanding cases. But implementing GMP in all its facets and living it represents a challenge. Ultimately a comprehensive GMP system is only as good as its comprehension, acceptance and actual realisation in practice. The human factor plays a crucial role with the knowledge, understanding and integrity of people. Establishing a basic understanding on a broad basis and anchoring in-depth knowledge where required is essential.
Establishing a Basic Understanding
Employees are often asked to work strictly according to the regulations defined by SOPs – standard operating procedures. But when a basic understanding of the background and meaning is lacking, this is difficult and serious errors or deviations may result. This is where basic training provides the required fundamental knowledge – what does GMP mean, where does it come from, what philosophy and objectives are behind it? What are the key requirements and how do they affect specific processes in the operation? Why are audits and inspections so important? Here the focus is on the required awareness and fundamental involvement of the employees.
Making Complexity Comprehensible
GMP and related specific topics are not detailed and tangible for many, some of the terms pure gobbledygook. This is where gempex offers a broad range of specialised training, such as:
- the organisation of a GMP operation
- validation practices
- GMP-compliant facility design
- data integrity
- Good Distribution Practice (GDP)
- Site Master File
- and much more
One thing all these specialised training offers have in common is that gempex with many years of practical experience places great emphasis on presenting the content in a simple and comprehensible manner. Complex topics are made understandable through technical expertise and educational skills.
Reliable methodology – frontal is good, together is better
Naturally the need for frontal presentations cannot be eliminated entirely. Yet the way knowledge is shared has long since changed: participants are actively involved in the process. In the form of workshops and exercises, they put what they hear directly into practice. Active participation supports the transfer of knowledge, making new information easier to process and retain reliably. This results in optimum preparation for the implementation in everyday operations. Next to certificates and documentation, what really counts is the reliability of GMP in practice.
Individually Tailored, Comprehensive Training Programs
The range of training programs offered extends from basic to specialised training and from workshops to one-on-one coaching. Details of the training content, target groups, modes of execution and desired goals are coordinated in advance and adapted to individual needs. While gempex has ready access to a large selection of training materials, no two training programs are the same.
- basic knowledge and fundamental awareness for employees
- complex and difficult topics made simple and comprehensible
- improved acceptance helps prevent errors in the GMP environment
- individual training adapted to target groups, topics and companies
- practical training by trainers who actively implement GMP themselves on a daily basis
- proof of training according to GMP