CAPA in the Pharmaceutical and Biotech Industries

Jackelyn Rodriguez has over 28 years of experience that cover all facets of quality assurance and regulatory compliance. Ms Rodriguez is the President of Monarch Quality Systems Solutions, a consulting firm serving in the technical and regulatory compliance capacity for several Pharmaceutical, Biologics and Medical Device manufacturers. Her consulting activities place emphasis on all aspects of regulatory compliance, training, Mock FDA audits/assessments, regulatory affairs and various FDA-related activities. Ms Rodriguez has published numerous compliance-related articles and has been a global industry speaker and presenter on several compliance topics. Her wide-ranged experience and recognized expertise in these areas have acquired her guest speaker positions worldwide. She has worked closely with CDRH’s FDA HACCP team for both promotion of Risk Management, training of over 1000 individuals, and worked with the FDA in their pilot study created to introduce the new Hazardous Analysis and Critical Control Points (HACCP) Inspection Technique to the Medical Device Industry.

Step-by-step basics on how to build a comprehensive CAPA program
How to use a nine step CAPA process to effectively handle any product or quality system failures
How to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely manner
How to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on risk
How to use Failure Mode and Effect Analysis to identify potential failure modes
How to review data from post production, and post market in order to determine the need for changes as well as new mitigations activities
Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions
Efficient use of root cause analysis tools
Optimizing CAPA and RCA documentation procedures
Essential SOPs and other documentation
Review areas of common FDA’s 483 inspection observations
How to effectively identify and track deviations and non-conformances
Learning to analyze and trend data to identify existing and potential causes of non-conformance
Gathering, organizing and managing the correct data required to conduct an effective Root Cause Investigation
Review the elements of a good investigation
Integrating RCA and CAPA with other systems such as: Internal auditing, deviations, Out Of Specification (OOS) and complaint handling
Performing trend analysis and using effective RCA tools
How to use of statistical methodologies when performing Root Cause Analysis
CAPA and the linkage to effective management review and annual product reviews
Step-by-step basics on how to build your own comprehensive CAPA program
Most important: Review of the real benefits of an effective CAPA system