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How Creating a Culture of Quality Will Benefit Compliance
Ensuring that policies and procedures are in line with cGMP compliance and regulations is also another element to making sure quality is embedded in your culture. Procedures need to be easy to understand, yet detailed enough to make sure the process maintains its compliance. Proper training of employees on these documents and processes is another key to success.
Once all of these variables are working together, the organization should start seeing a marked difference in the way their employees think about quality. It becomes less “a flavor of the day” and more a way of life. This whole process should not take much time or resource as it requires elements that are already present. It does require a group effort to make it successful.
Overview of the webinar
In today’s ever-increasing regulations in the Pharmaceutical world, companies have been setting stricter rules and regulations for their employees to follow to ensure they are within compliance with their regulatory authorities. It may seem like these drug makers are not concentrating on quality, meaning the quality of the process, the quality of the batch, the quality of the final product or the quality of the whole operation. As a result, we have been seeing the public relations nightmare of drug recalls, adverse events and company closures.
Who should attend?
Quality Assurance/Quality Control Directors, Managers, and Specialists
Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
Why should you attend?
Organizations that foster the development of a culture of quality usually have less employee turn around, less employee frustration and more successful regulatory inspections. A successful quality culture does not happen overnight, however. It takes a commitment from upper management, mid-line managers and shop floor employees to be able to sustain such a benefit. But what drives cultural quality as a necessary element in an organization? Is it a quality motto? A monetary award for employees that have zero mistakes? All of these things are nice-to-haves but in order establish a solid culture of quality there are a few elements that are needed to sustain such a philosophy. This webinar will highlight those elements that are needed for sustaining a quality culture.
Faculty - Miss.Danielle Delucy
Danielle DeLucy, MS, is the owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.