Documentation - Develop & Implement an Efficient and Compliant System (FDA Compliance Train)
Venue: Online Event
|Event Date/Time: Jul 11, 2011||End Date/Time: Jul 11, 2011|
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:
Regulatory Affairs professionals
Quality Assurance personnel and management
Quality Control personnel and management