Course Description

This exciting offering from JANAAC looks at imparting the necessary knowledge to clearly understand and interpret the requirements criteria found within the Code of Federal Regulations (CFR) 21 Chapter 1-Subchapter A-Part 1-Subpart M and FDA guidance documents. It provides participants with the knowledge required to strengthen food safety management systems operations and ease of access to the US market through local based FDA audits.

Learning Outcomes and Topical Outline

• Understand the FDA Requirements and the part that JANAAC plays in this FDA Third Party Program;

• Understand the requirements of the different scopes under the FDA Third Party Program and the use of guidance documents;

• Understand the FDA Requirements for certification bodies/entities seeking accreditation to the FDA Program and the necessary checklist;

• Be knowledgeable in what to expect/look for in an FDA Third Party Audit.

Pre-requisites

Basic/Fundamental knowledge of good manufacturing practices. Basic knowledge of hazard analysis critical control points (HACCP) is an asset.

Target Attendees

· Entities providing food safety audit

· Entities seeking FDA recognition to conduct FDA audits on behalf of FDA

· HACCP Coordinators

· Food Processors

· Quality Management team within entities seeking accreditation or a part of an already accredited entity

· Consultants

Areas of Focus

i. The Benefits of Accreditation

ii. General requirements for certification bodies/entities seeking accreditation;

iii. FDA’s Regulation (Subpart M) and related FDA guidance documents (checklists)

iv. The requirements of the different scopes under the FDA Third Party Program and other guidance documents.