How can you create a GMP training plan for new employees?

All personnel working in a regulated environment need to know the basics of Good Manufacturing Practices. These are rules coming from health authorities around the world, e.g. FDA or EMA. GMP basics cover: Quality Systems, Personnel, Premises and Equipment, Documentation, Production, Quality Control, Outsourcing, Complaints/ Recalls and Self Inspection. These are a minimum that personnel should be aware of and receive training on. There are further Annexes that dive a little deeper on subjects like Computerized Systems, Qualification, ATMPs and Sterile Prducts. Training should be tailored depending on the role. We have created 60 training modules to help universities and companies increase GMP knowledge.

First and the most important is to identify your audience. GMP is not an easy subject to understand for people who have never experienced a GMP environment. GMP is a set of rules and cultural behavior which needs to be presented differently for different audiences. You must think about your audience and deliver the training and training goals in an easy way.

In designing the GMP training COURSE, there should also be a section to discuss Biosafety and Biosecurity and there synergy and conflict with GMP.

Below are some points to get started on GMP training plan - Create an Operating Procedure and describe production environment and class as per FDA regulations - current GMP is a part of 21 CFR part 210 and 211 and make them aware of these regulations - Identify which group of individuals needs to be trained in their respective areas of expertise depending on their roles and responsibilities. - Provide examples of different industries and how it applies to their own company - Failures to follow cGMP could potentially impact product quality to customer and financial impact to company and their reputation

Historical Data Review: Within an established firm, historical data (inspection NCs, deviation Logs, etc.... ) review has a great impact on deciding training needs. For example, if you see a high rate of documentation errors from a specified employee or group of employees, you should address GDP in the training needs. Job Description > Skill Matrix: Initial training needs could be determined basically based on the required skills for a specified job.?

One thing i should add here is keep it simple and short By curating relevant, accurate, and engaging content, you'll effectively convey GMP principles to new employees, helping them understand not only the "what" but also the "why" behind these practices

Develop training packages based on real-life examples, especially where incidents / issues have arisen in your company. These could be based on deviations, customer complaints, product recalls, regulatory sanctions, etc. So: * What happened? * Likely causes? * Which GMP regulations / processes were not complied with? * Why not? * Which local SOPs were not complied with, or alternatively have gaps? * RCA and possible CAPAs? Real issues / incidents bring it home to staff and have more relevance.

Training topics should be tailored to the role new personnel will be performing. “Nice to know” topics should be saved for future development or cross functional training. Documents sometimes contain a single passage with a requirement applicable to all personnel. Consider alternate training methods to reading the SOP, particularly if they are lengthy, to ensure the key message is not diluted with processes the new person will not perform.

When selecting GMP training content, consider employee preferences and learning styles for better engagement. Encourage feedback to continuously improve materials and adapt the training plan to meet evolving organizational and industry needs. Personalization and feedback loops enhance training effectiveness.

Flowcharts are a visual way of representing a process or procedure. They can be used to illustrate the steps involved in a GMP activity, as well as the decision points and potential outcomes. This can be helpful for understanding the GMP requirements and how they apply to a specific process. For example, a flowchart could be used to illustrate the steps involved in cleaning and sanitizing a manufacturing equipment. The flowchart could show the different steps that need to be taken, as well as the decision points where the operator needs to make a judgment call. This could help ensure that the equipment is cleaned and sanitized properly, according to GMP requirements.

There is a certain amount of SOP reading that will be required for new personnel, but that cannot be all they do or the SOPs will blur together and the information won’t be retained. In manufacturing spaces, try to have personnel read the governing document and then demonstrate and/or perform the process the same day to help cement the connection. For less hands-on procedures, a discussion and/or simulation can do the same. People have different learning styles so do your best to account for each when you select your methods.

Consider incorporating digital learning for flexibility. Implement assessments to gauge progress and refine training. Foster a culture of continuous learning, empowering employees to take charge of their development, ensuring GMP compliance, and maintaining product quality.

Employers & Leaders need to find new ways instead of traditional training methods like Gamifications. Gamification is the use of game-like elements in non-game contexts. This can be a fun and engaging way to learn new information and skills. Gamification can be used in a variety of ways, such as: Creating interactive quizzes and games -Using points, badges, and leaderboards to track progress -Creating challenges and quests

Step 1: Training by SOPs Start training with the help of the trainer Then, each employee will have a specialized interview panel i.e. GMP panel. After that each employee can start a specific process

Incorporate feedback loops for continuous improvement. Connect assessment results to tangible outcomes like reduced errors and improved product quality. Stay updated with industry standards for long-term compliance and competitiveness in your GMP training plan.

In my experience most effective way of checking effectiveness of training or learning is following : 360-degree feedback: This is a process where employees receive feedback from their peers, managers, and subordinates. This can be a valuable tool for assessing the effectiveness of GMP training, as it can provide feedback on how employees are applying their knowledge and skills in the workplace.

Start with the basics: * What is GMP? (Emphasise the 'c' in c-GMP) * Why is it important? (Emphasise that the right quality results in Patient Safety, Regulatory Compliance and Business Improvement) * Who needs to follow it? (EVERYONE, but especially those in a role that "touches" the product) * What happens when it goes wrong? (Impacts on patient safety, approvals of new products and continued supply of existing products, business profitability, corporate reputation)

In addition, consider creating a supportive learning environment that encourages open communication. This perspective fosters a culture where employees feel comfortable asking questions and seeking clarification, ultimately enhancing their understanding of GMP principles and practices. It's vital to adapt training as needed to accommodate individual learning styles and pace while ensuring everyone grasps essential concepts. This approach promotes a more engaged and effective learning experience.

The training eficacy must be assessed for each training session. The trainee IS not alowed to perform a task if the training result IS not IS compliance with the requirements.

Also how was it received did it work for all did they enjoy it or have any suggestions to improve. How frequently do you receive data and review going forward … keep it fresh

Observing employees in the workplace is most effective way of checking implementation of GMP training plan : some specific questions may ask or observe: -Do employees have the knowledge and skills necessary to perform their jobs in accordance with GMP regulations? -Are employees aware of the GMP regulations and procedures that apply to their work? -Are employees able to follow GMP procedures and practices in the workplace? -Are employees able to identify and report potential GMP violations? -Are employees' training records up-to-date and accurate? -Are employees' training materials relevant and up-to-date?

One of the very first GMP trainings I attended as an employee (and a new hire) included a brief history of GMP regulations. Knowing the “why” is critical for trainees to understand what the regulation is supposed to do and why it was necessary. For me, knowing why also helps with relating to and accepting the regulation. That GMP training introduced me to Upton Sinclair’s The Jungle, which led me to find Trick or Treatment by Ernst and Singh. Knowing the motivation behind the regulation helps you be more creative when finding compliance solutions too, and reinforces principles of integrity, ethics, and patient safety.

I work in regulatory compliance and have found that employees are much more likely to retain the GMP training when given a brief history of GMP regulations and the tragedies/events that preceeded them. My usual examples are elixir sulfanilimide, thalidomide and the current DEG contamination events. I find it allows people to focus on why we have these regulations in place and to keep the focus on the ultimate goal of patient safety.