Webinar Details:

This ninety-minute course covers the basics of life science company requirements for completing documents with recognized good documentation practices to ensure the integrity of the data collected in regulated industries. These data practices ensure the safety and efficacy of products designed to protect end users (patients). It covers many aspects of the type of documents that regulators may audit and how this data is used to make business decisions about releasing or rejecting a product based on the recorded evidence. Participants will see regulatory observations for documentation deficiencies and common industry mistakes, so they can avoid these pitfalls.

Course Objectives:

• Understand the regulatory requirements for having documents and records.
• Review typical procedures for maintaining Good Documentation Practices.
• Understand the concept of data integrity related to records.
• Review Title 21 CFR Part 11 requirements for electronic records and electronic signatures and record-keeping impacts.
• Gain an appreciation of Good Documentation Practices and their impact on Data Integrity.

Course designed for:

• Manufacturing associates
• Quality control and quality assurance associates
• Material handling associates
• Purchasing associates
• Engineers
• Management
• New hires

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people

Register for ECC-764