More specifically, training must be done and documented manually or electronically if you add, modify, or impact any of the following 10 areas:
Specification criteria for raw materials, internally/externally manufactured components, or internally/externally finished products
Packaging or labeling information, process, or materials.
Tools or consumables (i.e. wipes, gloves, shoe covers, etc.)
Equipment or equipment settings
Cleaning processes of the manufacturing environment or manufacturing equipment
Locations for manufacturing, testing, sterilization, or warehousing
Environmental conditions of manufacturing, testing, or storage,
Control of monitoring processes for the manufacturing, testing, storage, or distribution environment
Any change that can potentially impact form, fit, or function and the quality of the product.
HOW TO AVOID MISTAKES DOING GMP TRAINING.
We suggest evaluating your current personnel positions to determine which procedures, forms work instructions, and training requirements to operate the equipment and materials in each area, but, also consider the frequency of re-training.
If you have a small number of employees to be trained, you can initiate a GMP training effort manually using hard paper. In case you need to create or update your cGMP training procedure, you can use a template procedure to accelerate the process to implement a manual Training Management System.
To download a cGMP training procedure template fully editable in MS Word format, ready to fill, and use according to your cGMP needs, click here.
To see the complete list of the most popular cGMP quality procedures templates, click here.
Moreover, you can use free software applications to handle your Training Management System (eTMS) and facilitate the process when is necessary a GMP Training.
To get free training management system application software, click here.
TO RECEIVE NEWS AND USEFUL TOOLS WHEN IS NECESSARY A GMP TRAINING, SUBSCRIBE, AND FOLLOW US.
CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. Rest assured of the safety or being in the right hands.
CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!