Effective Internal and External Quality Assurance Auditing for FDA Regulated Industry

Course "Effective Internal and External Quality Assurance Auditing for FDA Regulated Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Principles and Audit Planning
Planning and preparation
Internal audits are critical element of your quality management system.
Your approach must be both systematic and documented to remain compliant
Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes
Audit types and techniques
Establishing an audit program for suppliers, contractors and company sites
Internal vs. external audits
The audit processes
Regulatory Expectations
How to develop and implement an efficient and effective audit program
Common problems
Red-flags that your program is not effective
Risk Analysis techniques
Audit Program Structure
The auditing process - steps and tools
Documentation and communication
Linkages within your Quality System to ensure audits lead to effective solutions and lasting improvement while reducing regulatory and compliance exposure