This documentation training session will provide valuable assistance on how to assure your documentation is in full compliance with the regulations and the agency expectations yet yielding efficient operations meeting your business needs.
Why Should You Attend:
Documentation is a cornerstone of operations in the GMP world. On paper it looks so simple but so many companies fall foul of the law and regulations and get cited for poor documentation.
Using the regulations in USA, Canada and the EU, this webinar will supply guidance on the requirements for documentation. Attendees will understand how compliant and financially successful companies translate these requirements into rugged processes that are compliant and yet are efficient.
We will discuss the use of simple tools to make your documentation work for you and serve you rather than becoming a burden on you. With these tools you will be able to benchmark your processes against those of other companies. The speaker will also present examples of companies that have received warning letters from the FDA, to help you understand the challenges and how common errors happen: thus preventing you from making the same errors.
Areas Covered in the Seminar:
- Components of a compliant and efficient documentation program.
- Understanding regulations that apply to documentation.
- How to put into place a compliant and effective documentation system?
- What the key elements for compliance are?
- How to streamline and benchmark your current system.
- Good and bad document practices.
- What being in compliance looks like to the agency?
- Simple formats to make your life easier.
- Where companies make costly errors with agencies so you do not have to?
Who Will Benefit:
This webinar will provide valuable assistance to all companies operating under GMP who rely on their documentation systems for their business processes and which are inspectable by the agencies. The employees who will benefit include:
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Senior Management
- Regulatory Affairs professionals
- Quality Assurance personnel and management
- Quality Control personnel and management
- Compliance auditors
- Manufacturing management
Instructor Profile:
Peter Calcott , Ph.D. is founder and President of Calcott Consulting which serves the biotech, pharma and venture capital industry. It provides consulting services in supply chain, quality systems, clinical development, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.
He has held positions in industry in all these disciplines over a 30 year career. He has presented at national meetings and is active in the biotechnology community via BIO and the bay area BayBio trade associations where he is chairman of the BIO RAC committee and a Board member of BayBio.
Topic Background:
Documentation is a cornerstone of operations in the GMP world. On paper it looks so simple but so many companies fall foul of the law and regulations and get cited for poor documentation. These citations are lurking in areas as different as investigations, complaints, recalls, lot disposition, validation, CAPA, annual product reviews, on the manufacturing floor and the laboratory. There are few areas that are immune to the effects of poor documentation.
2009 and 2010 warning letter citations point directly or indirectly to this area. Why is it that something so central and simple causes so much angst? It is because it is an overlooked area: one that can be remedied very easily.
