The Center for Professional Innovation & Education (CfPIE), Malvern, PA
Jan 29 & 30, 2007
Who Should AttendPharma, 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. Learning Objectives Upon completion of this two-day course you will be better able to implement efficient practices that meet full GLP/GMP/ICH, ISO, and other regulatory requirements. In addition, you will better understand the following: • The 21 CFR Part 11 Electronic Records; Electronic Signatures, Final Rule requirements for managing documentation electronically, as well as 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 and 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’s 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 Course Description If you didn’t write it down, it didn’t happen! This is the position of FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. Good documentation is vital for due diligence and regulatory inspections, and it is vital 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, and what documentation you need to support your actual system, as well as how to keep your documents current and compliant. ________________________________________ COURSE AGENDA DAY ONE • Implied and explicit regulatory requirements for documentation
• Industry standards
• Documentation from discovery through marketplace
• Management support
• The documents you need to control, from source data to dossiers
• Components of document systems
• System administration
• Document review, approval, and revision
• Document distribution, retrieval, and archiving
• Determining “how it needs to happen here” DAY TWO • Going electronic from a manual system
• Features of electronic record keeping
• Understanding e-system requirements: validation, security, accountability, and audit trails
• Validation documents
• Standard Operating Procedures and other documents to support the system
• Writing sound procedures
• Consistency in format and terminology
• Training requirements and training documentation
• Remaining “inspection ready”
• Auditing the system
• The system over time: anticipating change
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