The FDA requires organizations to plan, implement, and maintain processes and procedures to keep consumers safe from foodborne illness. Establishing and maintaining a well-functioning documentation system for this plan can be a big challenge for businesses. Documentation provides legal evidence that you and your employees are following the practices and procedures that are deemed necessary for safety. Participants in this course will gain a clear understanding of documentation expectations of the TTB and FDA. They will practice creating, using, and correcting documents intended for product safety and traceability. Participants should walk away with the knowledge of how these documents and these practices will be useful to them during recalls, audits, and trending analysis.
Food and beverage quality assurance professionals, production staff, document control, doc review, safety supervisors, regulatory affairs personnel, auditors, and anyone involved in implementing or managing food and beverage production. The course is designed for persons working in alcoholic beverage production, packaging, and contract manufacturing. This may also be useful for those in adjacent businesses such as yeast production, distribution, or suppliers for the industry.
- Regulatory Standards
- Document Creation
- Document Control
- Good Documentation Practices
- Document Storage and Access
- Data Analysis
- Describe documentation management for alcoholic beverage manufacturing
- Understand what documents you may need and why they are important
- Describe what documentation practices are expected from regulators
- Explain how to create traceable documents
- Explain who can access documents, when, and how to access documents
- Describe the importance of document change control
Group exercises include:
- What is your current documentation system like at your facility
- How to find resources and guidance from your government agencies
- Practice creating a basic format for your company’s documentation
- Correct mistakes made on the given document
- Supplier, buyer, and distributor document control: How would you manage documentation from external parties? What checks would you put in place to ensure you are receiving this documentation.
- Given this set of data, identify the trend that the data is pointing to.
Delivered online with a live instructor at a scheduled date and time.
Intermediate
