483s can occur in any life science organization. FDA audits often lead to form 483s; they are issued the primarily for not meeting the regulatory requirements in practice. While some 483 audits are resolved amicably; some cases have serious consequences for the concerned organization, ranging from receiving warning letters to paying heavy fines. The costs and implications to the company can be staggering. The cost of a 483 is significant but unique to each company. In general, the cost includes – reputation damage, competitor leverage, loss of business, lost stockholder confidence, and diversion from the job at hand, none of which a life sciences company can afford in today’s competitive environment.
Unfortunately, most regulated industries don’t have a set approach for developing a compliance program that is integrated into the fabric of their organization with the goal of avoiding 483s and which serves real valuable functions, such as: improving operations, improving and maintaining human competence, and enhancing competitiveness. Compliance and regulatory affairs are viewed in many cases as a “non-value add,” which is an expense and not an asset; it is a “check-the-box” to be completed in the event of a regulatory audit or issue and because it is required.
Your organization must create a compliance program that helps you avoid 483s. You must standardize your operations and build your operations around safety and efficacy. You must structure an organization that exceeds your regulatory responsibilities, while at the same time, optimizing every function within the company that the regulatory processes touch. Avoiding 483’s and adverse findings, if the strategies are executed properly, will also significantly contribute to achieving operational excellence. The most simplistic solution to achieving compliance excellence and avoiding 483s is “to do the right things right!” However, what does it really mean?
Join this session with regulatory compliance expert Charles H. Paul, who has distilled the “doing the right things right” solution into 7 separate individual keys or actions that will provide a solid foundation for the establishment of any 483 avoidance program. In this session, Charles will provide you with the strategies for not only avoiding 483s, but also for improving all facets of your company’s operations.
Charles will discuss the approach and framework that you need to follow to make your compliance program a valuable ingredient in the process of running your business. This session provides the significant benefit of avoiding 483s and other adverse regulatory reporting, while at the same time, achieving a measure of operational excellence.
This session will help you understand:
Who Should Attend
This session is applicable to the entire life sciences industry, for:
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Charles H. Paul
- Charles H. Paul
- Charles H. Paul
- Joy McElroy
- Angela Bazigos
- Larry Spears
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence....
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