![]() It also provides corporate strategy development, analysis and assessment especially due diligence evaluation. It provides consulting services in supply chain, quality systems, clinical development, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. is founder and President of Calcott Consulting which serves the biotech, pharma and venture capital industry. Quality Control personnel and management.Quality Assurance personnel and management.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. Where companies make costly errors with agencies so you do not have to?.Simple formats to make your life easier.What being in compliance looks like to the agency?.How to streamline and benchmark your current system.What the key elements for compliance are?.How to put into place a compliant and effective documentation system?.Understanding regulations that apply to documentation.Components of a compliant and efficient documentation program.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. With these tools you will be able to benchmark your processes against those of other companies. 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. Attendees will understand how compliant and financially successful companies translate these requirements into rugged processes that are compliant and yet are efficient. ![]() Using the regulations in USA, Canada and the EU, this webinar will supply guidance on the requirements for documentation. On paper it looks so simple but so many companies fall foul of the law and regulations and get cited for poor documentation. Documentation is a cornerstone of operations in the GMP world.
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