COURSE BUNDLES WITH PHONIZE
FDA Inspections for FDA Regulated Companies Bundle from PHONIZE
Now on Mobile Devices
COURSE BUNDLES WITH PHONIZE
FDA Inspections for FDA Regulated Companies Bundle from PHONIZE
Now on Mobile Devices
Inspection by the FDA or other foreign regulatory agencies for the purpose of certification is a normal part of the pharma, biotech or medical device manufacturing business. Regulated companies need to know the structure and typical processes of a regulatory agency inspection to ensure a positive outcome. This course bundle was co-developed with former FDA Inspector Larry Spears and contains comprehensive information on all inspection information.
WHAT YOU WILL LEARN
This module bundle clearly presents the facts about expected inspection processes for organizations focused on pharma, biotech and medical device manufacturing.
This bundle trains personnel to meet inspection expectations and avoid pitfalls that often occur due to lack of knowledge or preparation. It is vital to company success for managers and quality assurance personnel to be aware of the requirements of inspection procedures.
“Our quality managers enjoyed using PHONIZE and I appreciated how time and resource effective it is to offer mobile training to my staff.”
AVAILABLE LEVELS
BASIC & INTERMEDIATE
TOPICS COVERED
- FDA Inspection Program Overview
- Key factors for a successful FDA inspection
- Quality System Readiness
- Information Readiness
- Organization Readiness
- Manage Inspection Outcomes
- Managing Regulatory Risk
- Food Facility Inspections
- Medical Device Inspections
- 21 CFR 11 Inspections
- FDA Quality Metrics
- Corrective and Preventive Action (CAPA)
PERFECT FOR
- Senior Management
- Quality Assurance and Control Managers and Personnel
- Supply Chain and Logistics Managers
- Regulatory Affairs Professionals
- Process Development Scientists and Management
- Manufacturing Personnel
- Project Managers in the CMC arena
- Facilities and Engineering Staff
- Internal Auditors
- Legal Departments
Expert preparation for hosting regulatory inspections
provides insight, improves processes, reduces citations and other negative circumstances, and improves work consistency.
Utilizing a risk-based approach,
this course provides a comprehensive overview of different inspection expectations in regards to quality system readiness, organization readiness, how to manage inspection outcomes and other important processes.