Tip 1: Create Job Descriptions
You might be asking yourself ... "What do job descriptions have to do with creating effective training programs for FDA and ISO Compliance?" The answer is EVERYTHING. When you create comprehensive job descriptions, you are creating your company's intellectual road map for a compliant training program.
The Quality System Regulation states that Medical Device Companies must "have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required are correctly performed" [21 CFR Part 820.25(a)].
ISO 13485:2016 states that "Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience." [ISO 13485:2016, 6.2]
Step 1 - Identify what activities are required in your organization to produce safe and effective medical devices. This includes all positions that can affect quality (not just manufacturing).
Step 2 - Organize those activities around positions in the company that will be held accountable for completing those activities.
Developing an effective training program for compliance largely depends upon how well you are able to articulate the activities required to get the job done. The rest is about how well you organize the training and document the results.
Tip 2: Develop Tiers of Training Curricula
Now that you know what needs to be done, you can start thinking about how you're going to train people to perform the duties correctly and consistently. Planning your training programs around business effectiveness, process efficiency, and compliance is a balancing act. The key to achieving a successful balance is a tiered approach.
Top Tier: All Employee Training
All employees working in a regulated environment need baseline training for what it means to work in a regulated environment but they also need to understand the overall structure of your company's quality system. These two areas are usually covered in a Quality System Basics course and Quality Manual training.
Second Tier: Job-Specific Training
Pull out those great job descriptions you created and start organizing training curriculums that are specific to the jobs you have. Anyone with the same job description will be required to be trained in the areas specified.
Third Tier: Employee-Specific Training
In today's market, employees are always expected to perform additional "roles" in the company that can't always be tied specifically to a particular job description. This is where you put those critical one-off training requirements. For example, Medical Device companies are required to have an internal auditing program. There are specific training requirements that must be completed before an employee can be adorned with the "Internal Auditor" title. This is a great place to document those training requirements.
Tip 3: Maintain Training Records
Training Records are most dynamic element in any regulated training program and, as such, they are the hardest to manage. Consequently, it is of paramount importance to stay on top of your company's training records. Remember, training records are the only evidence you have to prove that you've successfully trained the organization to ensure that business and regulatory requirements can be met consistently and comprehensively.
Put these three tips into practice and you will be able to rest easy knowing that your training program is under control and fully compliant with the most prevalent regulations and standards applicable for medical device manufacturers today.
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