Who Should Attend?
This course is intended for life science professionals within any and all types of companies that are regulated by the US Food and Drug Administration and similar global health authorities. The training will be beneficial to everyone from Assistant Managers to Senior/Executive Directors in departments such as:
• Q/A, Q/C and Quality Operations
• Technical Operations
• Supplier Quality
• Clinical Quality Operations
• Tech Trans & Commercialization
Anyone who is involved with writing or reviewing quality record documents with job functions such as CAPA, investigations, validation and quality documentation departments should also attend this training.
While this is not an entry level course, it is recommended that anyone with less than five (5) years of FDA-regulated industry experience or experience writing, reviewing, or approving quality records should familiarize his/herself with the multitude of document types critical to a FDA-regulated company.
John C. (Jack) Garvey, Esq., founder of Compliance Architects LLC, is a diverse, collaborative, highly-experienced quality, regulatory and compliance expert with an exemplary record of accomplishment in FDA-regulated industry. During Jack’s long tenure working in life sciences companies, Jack held leadership roles focused on compliance and quality strategy development and deployment. In addition to successes at leading companies such as Accenture, Johnson & Johnson, BASF, and C. R. Bard, Jack’s dual background in law and engineering provides unparalleled ability to resolve today’s complex quality, regulatory, and compliance issues. Jack’s unique background provides an ideal blend of legal and scientific advocacy that can yield robust and effective quality and compliance systems and improved compliance outcomes for contemporary quality and compliance challenges.
Jack has developed innovative compliance approaches focused on risk differentiation, improved compliance outcomes, and operational cost control, and is a frequent speaker at industry conferences. Jack received his Bachelor of Science in chemical engineering from Clarkson University and his Juris Doctor from Pace University School of Law, and is admitted to practice law in the states of New York and New Jersey.
The primary avenue for which FDA judges a company’s conformance to cGMPs and ultimately the approval of regulatory submissions is through their review of documentation. The success or failure of an FDA-regulated company often comes down to the quality of these documents. While most professionals have spent years learning and mastering their technical expertise, mastering quality writing is rarely a part of this development.
Writing for Compliance® is a breakthrough workshop training that is FDA-regulated industry’s first and only formal training program devoted to improving FDA and regulatory inspection outcomes through improving writing skills within regulated companies. Writing for Compliance® is a fast-paced, interactive workshop that is filled with practical information, insight, tips and defined approaches to help your company’s personnel improve their writing skills. This 12-hour accredited program, delivered over 3 consecutive days is structured as a two-day interactive workshop that includes five workshop exercises, each based on actual quality records and inspection-target documents commonly used within FDA-regulated companies. Classroom materials provide background on the problem of writing, recognizing non-compliance documents, and the Writing for Compliance® structure document writing process.
Using the Writing for Compliance® Structured Document Process attendees become acutely aware of what to look for in deficient documents and how to re-write these documents to minimize questions from FDA Investigators.