Who Should Attend
Pharma, medical device, and biotech professionals who manage documents for all therapeutic product development and marketing activities (including pre-clinical, clinical, QA, and regulatory functions) should attend. This two-day course is also valuable for QA auditors who need to understand what constitutes sound documentation and documentation management.
Upon completion of this two-day course attendees will increase their ability to implement efficient practices that meet full GLP/GMP/ICH, ISO, and other regulatory requirements. In addition, participants will better understand:
- The 21 CFR Part 11 Electronic Records; Electronic Signatures, Final Rule requirements for managing documentation electronically, and the FDA’s predicate rules, such as 21 CFR Part 211, 58, and 820
- The common ground in all regulations, including the International Conference on Harmonisation (ICH) guidelines, the International Organisation for Standardisation (ISO), and the new HIPAA regulations for electronic records 45 CFR Parts 160, 162, and 164 Health Insurance Reform: Security Standards: Final Rule
- What is required to establish a sound documentation function within your work arena
- How electronic documentation systems work and what’s needed to keep them compliant
- How to go from a manual system to an electronic system
- What documentation must be in place to support the documentation function
- What documentation must be in place to support the company’s systems and processes
If you didn’t write it down, it didn’t happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don’t tell you how. Based on industry best practices, this course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls.
This course also addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant.