This cGMP's webinar/training beyond CFR110 will provide valuable information to food manufacturing companies, especially those who are not certified to ISO: 9001.
The FDA's documented cGMP requirements vary widely from industry to industry. There are, however, expected and implied requirements that are valid across many industries, including food manufacturing. Although certain requirements such as document controls, records, customer complaint handling, nonconforming material handling, labeling and packaging, acceptance activities, are not covered in CFR110, they are expected to be followed and can become the focus during an FDA audit if the inspector sees evidence that products or processes are at risk due to these basic cGMP subtopics are not being adhered to.
From an ISO standpoint, many of the exclusion in the FDA's cGMP's are in fact included in the ISO: 9001 Standards. Unfortunately companies who are not ISO certified are not aware of the expectations. All employees need to understand the importance of these basic functions on a quality system. This session will discuss what is expected in order to adhere to these universal requirements.
Areas Covered in the seminar:
- Review of cGMP's not included in CFR110 including: Document Controls, Records, Nonconforming Material Handling, Labeling and Packaging Controls, Acceptance Activities, Proper Documentation Practices.
- Examples of how to adhere to each of the cGMP's discussed.
- Why these cGMP's should be adhered to.
- Brief overview of the FDA's role in regulated industries.
- Ramifications of not following cGMP's.
- Linkage of Quality System elements.
Who will benefit:
This webinar will provide valuable information to food manufacturing companies, especially those who are not certified to ISO: 9001, as employees will have a broader understanding of the regulations, and will see that adhering to additional requirements is the right thing to do. The employees who will benefit include:
- Production and processing personnel
- QA employees
- Quality System auditors
Instructor Profile:
Phil Guarino, is a Managing Partner of Quality Solutions Now (QSN) a consulting firm providing regulated industries with expertise in project management, process improvement, quality system implementation and compliance, product and process development, as well as auditing and training support. Phil has entered his 22nd year working within FDA and ISO regulated industries. He has developed and implemented quality systems, performed over 200 cGMP audits, and has managed numerous FDA and ISO audits. Phil has developed and executed training programs for the medical device, Pharma, and food manufacturing industries throughout the US, Europe, Caribbean, and Asia.
