The basic definition of compliance is conforming to or adhering to a rule or a set of rules. Those rules are otherwise known as laws. Regulatory compliance describes the activities that organizations perform and accomplish to ensure that everyone in the organization is aware of the laws that apply to the work that they do every day, the controls that must be in-place to manage compliance, and the specific roles and responsibilities that everyone must assume.

What is the regulatory environment in the life sciences?  Well, the environment is very complex because of the regulations that apply. Even more significant, the FDA only provides general principles and direction (because of the wide range of products that they regulate), in other words the FDA is not prescriptive leaving companies to “figure it out.” They generally tell you what to do but not how to do it. Layer on top of that, the FDA assumes the role of auditing your performance while they expect you to be self-regulating.

This webinar will introduce and overview the concept of containing compliance costs – working smart.  The webinar will provide a comprehensive strategy for cost reduction in regulatory affairs and compliance by presenting strategies for complying with FDA regulations in a cost-effective manner. 

These strategies include:

Regulatory Documentation – Regulatory documentation is the most visible aspect of regulatory compliance. Documentation should not simply meet a regulatory requirement – a “check the box.”  It should be designed to effectively direct operations, be foundational to a comprehensive worker training approach, and  serve as the basis for a sound continuous improvement process, all while satisfying all regulatory requirements.

Independent Regulatory Audits – Independent audits are a vehicle to minimize the impact and intensity of FDA on-site inspections.  The key is retaining an auditor group that has high standards exhibited by independence, expertise (verifiable training and education), and experience.

Quality by Design – Quality by design is actually an FDA approach that was developed to aid in reducing compliance costs. There are three aspects to this process to include risk assessment, design space, and process analytical technology that together are foundational to regulatory cost containment.

Harmonizing your Processes - Inconsistency between operations although not necessarily a problem are cause for concern when those inconsistencies are uncovered during an inspection or investigation. Best practices should be determined for “like” operations, equipment, processes, etc. and then implemented across all facilities and locations where those “like” operations exist.

Effectively Handling Inspections – Advanced organized and structured preparation for FDA inspections can mean the difference between chaos and an unannounced intrusion and a demonstrated, well-organized, cooperative and compliant organization.

What is the result or impact of the regulatory environment on the business? Companies find themselves in the position of doing too little or too much relative to compliance because they are simply not sure. Too little in terms of compliance makes you vulnerable to the FDA’s auditing/checking function opening your company to a varying array of sanctions that could significantly impact your business. If you decide to eliminate your quality control and quality assurance function, for example, you will simply not be compliant no matter how effective and safe your product might be. 

Doing too much is costly in terms of the resources expended. In the life sciences, like it or not, regulatory compliance is expensive, it is intrusive, and impacts everything that we do. You don’t have significant latitude concerning what you can and cannot do relative to regulatory compliance within specific areas and still be compliant. Your only alternative is to work smart, be proactive and have a plan. This webinar is about doing all of those things.