QbD Training and Your Pharma Manufacturing Facility

For far too many years the industrial world has relied on the Quality after Design process to test the products they make to see how well they are made. It has been the job of a Quality Control Inspector to randomly sample the products to ensure that the rest all meet the required standards. In recent years the concept of quality by design was first introduced by renowned quality expert Joseph Juran, who believed that the quality of any product could be the result of proper planning. His belief was that with proper QbD training many quality issues could be stopped it the planning phase.

The FDA has been quick to acknowledge the concept and recommend QbD training for all pharmaceutical manufacturers where so many quality issues have plagued the industry for years. Not only has this training resulted in vast improvements in the area of generic and name brand drugs, but it has helped to create a new era of trust between the industry and the FDA. Notably, this process has served to improve the science of pharmacology significantly.

It is hoped that full implementation of QbD training will result in far less need for heavy regulatory oversight and will help to streamline the development and manufacturing process. This should be followed by lowered operating and manufacturing costs that can be passed on to the consumer. It should also serve to reduce the level of reporting requirements as the quality of each product is built in long before it goes into production.

When your staff attends QbD training they should learn what the concept of Quality by Design is and where it came from initially. They should learn what it takes to comply with the various regulations covering this program and how to implement the concept. These classes should cover reporting procedures and why products that are already established may not be accepted into the QbD program.

QbD training is designed to benefit all manufacturers involved in the manufacture of pharmaceuticals and biotech products. All employees should attend as the various courses are designed to cover every aspect of the manufacturing process from raw materials to the final product. Once training is completed, your facility will enjoy a much better product safety record, which can only serve to build significantly higher consumer confidence in your complete line of products.

If your facility is looking for QbD training, you will find that ComplianceOnline provides a full line of courses that are intended to familiarize your staff and teach them how to implement this program into your manufacturing process. Training is provide via online courses at a per person rate or via a CD that while it is designed to be used in only one facility can be used to train all members of your staff. It is time for your company to come into compliance with the latest quality control standards and meet the newest FDA regulations as required by your industry.