Understanding Industry Certification: Why It's Relevant and Necessary

In advance of our completely-updated course Process Validation for Drugs and Biologics, we have asked all participants to prepare examples of FDA process validation concerns and issues they have in their own companies for discussion in the session. If you are new to the business or otherwise unsure how to identify issues, we’d like to offer some pointers to make your attendance at the session as impactful as possible, and also help all pharmaceutical professionals identify process validation compliance concerns that may sideline the development of drugs and/or incur costly audits and drug recalls by the FDA.

At the outset, one of the most important things a firm can do for process validation is to develop and maintain a written testing program that describes stability characteristics and procedures for stability testing throughout the lifecycle of drug development. Such a process ensures that all drugs produced in your laboratory are consistent in strength, half-life, etc. but perhaps, more importantly, ensures that microbial contamination or spoilage are not present in any batches of product. It is the responsibility of senior leadership to ensure all employees of the lab act in accordance with the stability testing program, which is why the Process Validation for Drugs and Biologics course is geared towards both management and staff-level employees to keep everyone in your organization working towards the same goals.

Additionally, the three-step design of process validation is designed by the FDA to guarantee that procedures, when properly followed, will produce consistency in the performance of your drugs or biologics, the end result of which is consumer loyalty, both by the public and physician partners. Ultimately, process validation is not merely a safety concern - It keeps your product reliable, which makes the work of your marketing and sales departments much easier, resulting in higher quality products. Avoiding the obstacle of an FDA audit is a low bar for most businesses operating in our country - the ultimate goal of an excellent process validation system is ensuring your products are the best on the market in quality and in sales.

In the industries that CfPIE serves with certification programs, not a lot can be done without certain certifications. As an employee in these fields, you typically have to maintain a certain level of certification simply to prove that you have the necessary knowledge to work in these highly technical fields. But why, exactly, do these fields seem to be so dependent on certifications? What makes them so necessary? Here are a few reasons why industry certification programs are a huge benefit to you, your company, and the clients your company serves.

Certification Programs Benefit You First

Getting certified in updated technology, new procedures, or any sort of new method or tool is very beneficial for you as an employee. It shows that you have taken the initiative to maintain your training and keep up-to-date in the field. This can make you more employable, it can help you get a raise, and it can help you move up in your career. It can also help you work more efficiently and with more innovation in your daily tasks. You’ll not only stand out from others in your field when applying for new roles, you’ll also be able to then build on that certification by getting even more advanced certifications in the future.

Industry Certification Programs Benefit the Employer

As for the employer, there is always a desire to maintain a very polished and professional image in these types of industries. It helps companies get more clients, and positions them to be more profitable. Having employees with certifications reflects very well on the company – it says “We hire the best.” It can also help reduce the risks of audits or penalties, because employees with advanced certifications will have a better understanding of how to best perform their duties. Additionally, having employees with advanced certifications could protect companies from accusations of bad practices.

Certification Programs Protect Clients and Consumers, Too

When it comes right down to the final person affected by your work – the client or consumer – your knowledge of your industry can directly impact them. If you are more knowledgeable, and have the certification training to back that fact up, you produce something that is safer or healthier for the consumer.

Get Training with CfPIE

Your choice to go through industry certification programs impacts more than just yourself. In the grand scheme of things, it could impact millions of consumers, all your coworkers and bosses, and your family. This is why these certifications are important and relevant for anyone in these fields. You can find out more about CfPIE’s certification programs online at www.CfPIE.com, or consider having CfPIE come to you! Custom onsite training for your entire workplace could be the ideal way to keep a company up-to-date in an industry.