ZTLearning Growing Margins through Performance Improvements and adhering to all Compliance Regulations at the same time

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1 ZTLearning Growing Margins through Performance Improvements and adhering to all Compliance Regulations at the same time According to the 2013 Global life sciences outlook by Deloitte Pharmaceutical companies will need to improve operational efficiencies to grow margins. As stated in the FDA Code of Federal Regulations 21CFR (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. (b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. (c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product. ZTLearning recognise that one of the fastest ways to improve performance and become compliant is through elearning. ZTLearning have created a unique process to help our customers achieve consistent results from their teams. OOEDL provides the tools to allow you to identify weaknesses, support improvements and productivity, and maintain required levels of regulatory compliance through: Identifying team needs through pre assessments Support process and role-specific needs through simulation exercises Confirm competency levels through post assessments Allocation of certificates to validate and record approved knowledge levels

2 OOE DL - Overall Operations Efficiency DRIVERS LICENSE is a field-validated solution that combines performance improvements with regulatory compliance obligations. By identifying the tasks and responsibilities associated with a role and establishing the required levels of competency, ZTLearning applies our unique intelligent elearning engine that allows us to provide randomly chosen sets of specific assessment tests for the operators to determine their knowledge level. This allows training and supervising engineers to determine what levels of competency have been achieved before individuals actually perform key processes. The ultimate goal for all operators is to achieve the desired level of competency to receive their OOE driver s license thus allowing them to be eligible to operate at their required level of operational knowledge. OOE Overall Operations Efficiency focuses on the Performance improvement aspect of all roles, this is where we constantly take best practices, combine with a Simulation environment, and other great interactive training technique to ensure that the knowledge is transferred in the most efficient way possible DL Driver s License focuses on the FDA Compliance requirements; this is where we utilise our Assessment Engine that randomises test questions to ensure that a real assessment is undertaken with real results being provided from the system, and our Learning Management System allows for all compliance record management requirements. By ensuring that only qualified personnel are issued with the Driver s License, we allow all operations to comply with the requirements set out by the FDA.

3 ZTLearning have identified four key steps to performance improvement. By adopting the OOEDL model we believe that early identification and continual assessment is the key to consistency. As you can see below, by keeping the process simple but efficient we can see instant results. We believe based on the response from our customers where we have had this system successfully installed for over two years that this will see an immediate increase in performance, a decrease in process error, and will also reduce calls to the Help Desk. By increasing efficiency we believe that the financial savings can more than justify the investment in the OOEDL Model. We would strongly encourage you to try our ROI Calculator on our website to see how even a small percentage improvement can have a massive effect on the bottom line.

4 STEP 1 Pre Assessment: A Pre assessment course can be built to cover various banks of questions directly linked to the many process stages, the key to PRE assessment is to minimise the number of people who actually need to take update or refresher training. Training and assessments may be delivered by tablet or mobile to prevent the workforce from having to leave the production floor. Pre assessment courses are used to ensure your crew maintain the base level of competency, by routinely and randomly checking the team s level of knowledge you will identify which members need your immediate support. This level of support will improve confidence within the team and will result in process improvement.

5 STEP 2 Mapping Process to Role: As part of an OOEDL rollout, the ZTLearning team will work with the various groups on site to create a unique site-specific Training Matrix. It s important that everyone is clear on what courses, and more importantly, what levels of competency need to be linked with the various roles within the team. This exercise allows everyone to understand what they need to understand to perform their job effectively and efficiently. It s important to point out that even people who are not directly linked with a particular process can benefit immensely from taking various Overview or Introductory courses, this allows all levels within the team to understand all aspects of the processes linked to operations which results in much clearer communication within the group.

6 STEP 3 ZTLearning Interactive Courses: Once a training need has been identified we assign the required courses to the individual. The combination of the conversational audio, the interactive onscreen elements, and the clarity of the visual instructions, we believe that the student grasps the training quicker and with clearer understanding of the processes and concepts being focused on. By adding a controlled Simulation environment, and providing the customer with a suite of reports to help identify trends and team weaknesses, we are able to support all of the learning needs to help increase overall performance and reduce downtime. But online courses aren t just a training tool, given that these courses are available 24/7, and are presented in bite-size chunks, they also provide a Support mechanism for the team in the form of reference checks if a team member is not fully sure of the particular steps associated with a process, then they can quickly access the course, review the steps, and try out the simulation to validate their knowledge before completing the process in real time with a reduced risk of error.

7 STEP 4 Post Assessment: Post assessment ensures that all individuals who need to reach the required levels of competency have done so. It validates that the training has been successful, and it ensures that only team members able to perform the core functions without error are allowed to join the team. It is as this stage that all team members are either awarded the OOEDL Certificate, or if they are unsuccessful in passing the test, they are identified as either needing closer one on one support, or they simply may need more time to review the courses assigned to them again. This is the beauty of elearning, it s self-paced, which allows all students to find the pace that allows them to absorb the information best.

8 Summary: In conclusion, the OOEDL model allows for overall performance improvements, this has the result of seeing less error, less downtime, and an overall increase in productivity in your operation. As a proven commercial model we believe that OOEDL can help the modern workforce in many ways. This is more than training; it s an overall Performance Improvement Solution.

9 The Next Step: The first step is always the hardest, in ZTLearning we aim to make this as easy and clear as possible. We understand that it s important to validate any new approaches, and to clearly understand what s involved and what can be achieved, it s because of this that our next step is simple, we agree a time, come onsite, meet with a small group of key stakeholders from the various operational groups and hold a short Q&A session, from this we produce a proposal and suggested options to you for how best to implement a Performance Improvement Solution. For more details on our OOEDL model and our Performance Improvement Solution, please feel free to call or Paul Robinson, Director, ZTLearning Zenith Technologies Office: Cell: paul.robinson@zenithtechnologies.com " Your Global Life Science Training Partner "Leaders in Automation, Process Control and MES Solutions"