Adverse findings during a FDA inspection depending on their severity can have catastrophic results to the company, the function targeted by the findings, and management. Every associate within the organization is responsible for being compliant and having the skill and knowledge to properly interact with inspectors and manage the inspection process.
This virtual seminar will walk-through every facet of the readiness inspection from your selection to be audited, through the process itself, to the handling the outcomes and everything in between. This seminar will identify those critical to compliance areas that must be properly addressed to ensure fully compliant and inspection ready operations
Areas Covered in the Session :
- The mechanics of the readiness process, auditing – who gets audited, frequency of audits, and the inspection process explained
- Types of inspections and their implications
- The heart of compliance – doing the right things right
- Selecting your subject matter experts
- Training your SME’s – what do they need to know and how do you train
- Inspection preparedness – what to expect and how to prepare
- The readiness inspection from the auditor’s perspective
- Responding/interacting with the inspection team – inspection behavior – how to act – what to say and what not to say
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Compliance Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Validation Departments
- Marketing Departments
- Documentation Departments
- Logistics & Wearhousing Departments
- Virtually the entire spectrum of your organization
