FDA Recordkeeping Requirements 2014

Topics

• How to determine what documents you need to retain and for how long
• Types of regulated records required to be kept
• How to develop an FDA records retention schedule
• Example FDA enforcement citations for poor recordkeeping practices
• How to deal with email and records kept electronically vs. in hardcopy
• How to handle records maintained at your suppliers
• SOPs and policies you need to have

Who should Attend

• Regulatory affairs managers and professionals
• Quality managers and professionals
• Anyone interested in being able to prove compliance to the FDA investigator or a mock FDA auditor
• Document control/records management professionals and managers