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.

"...useful for anyone working in quality assurance or regulatory affairs as a reference guide and as a tool for setting up or improving CAPA programmes." --The Pharmacetical Journal

• Step-by-step basics on how to build a comprehensive CAPA programHow to use a nine step CAPA process to effectively handle any product or quality system failuresHow to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely mannerHow to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on riskHow to use Failure Mode and Effect Analysis to identify potential failure modesHow to review data from post production, and post market in order to determine the need for changes as well as new mitigations activitiesResponding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actionsEfficient use of root cause analysis toolsOptimizing CAPA and RCA documentation proceduresEssential SOPs and other documentationReview areas of common FDA’s 483 inspection observationsHow to effectively identify and track deviations and non-conformancesLearning to analyze and trend data to identify existing and potential causes of non-conformanceGathering, organizing and managing the correct data required to conduct an effective Root Cause InvestigationReview the elements of a good investigationIntegrating RCA and CAPA with other systems such as: Internal auditing, deviations, Out Of Specification (OOS) and complaint handlingPerforming trend analysis and using effective RCA toolsHow to use of statistical methodologies when performing Root Cause AnalysisCAPA and the linkage to effective management review and annual product reviewsStep-by-step basics on how to build your own comprehensive CAPA programMost important: Review of the real benefits of an effective CAPA system

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.

"...useful for anyone working in quality assurance or regulatory affairs as a reference guide and as a tool for setting up or improving CAPA programmes." --The Pharmacetical Journal

• Step-by-step basics on how to build a comprehensive CAPA programHow to use a nine step CAPA process to effectively handle any product or quality system failuresHow to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely mannerHow to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on riskHow to use Failure Mode and Effect Analysis to identify potential failure modesHow to review data from post production, and post market in order to determine the need for changes as well as new mitigations activitiesResponding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actionsEfficient use of root cause analysis toolsOptimizing CAPA and RCA documentation proceduresEssential SOPs and other documentationReview areas of common FDA’s 483 inspection observationsHow to effectively identify and track deviations and non-conformancesLearning to analyze and trend data to identify existing and potential causes of non-conformanceGathering, organizing and managing the correct data required to conduct an effective Root Cause InvestigationReview the elements of a good investigationIntegrating RCA and CAPA with other systems such as: Internal auditing, deviations, Out Of Specification (OOS) and complaint handlingPerforming trend analysis and using effective RCA toolsHow to use of statistical methodologies when performing Root Cause AnalysisCAPA and the linkage to effective management review and annual product reviewsStep-by-step basics on how to build your own comprehensive CAPA programMost important: Review of the real benefits of an effective CAPA system

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.

"...useful for anyone working in quality assurance or regulatory affairs as a reference guide and as a tool for setting up or improving CAPA programmes." --The Pharmacetical Journal

• Step-by-step basics on how to build a comprehensive CAPA programHow to use a nine step CAPA process to effectively handle any product or quality system failuresHow to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely mannerHow to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on riskHow to use Failure Mode and Effect Analysis to identify potential failure modesHow to review data from post production, and post market in order to determine the need for changes as well as new mitigations activitiesResponding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actionsEfficient use of root cause analysis toolsOptimizing CAPA and RCA documentation proceduresEssential SOPs and other documentationReview areas of common FDA’s 483 inspection observationsHow to effectively identify and track deviations and non-conformancesLearning to analyze and trend data to identify existing and potential causes of non-conformanceGathering, organizing and managing the correct data required to conduct an effective Root Cause InvestigationReview the elements of a good investigationIntegrating RCA and CAPA with other systems such as: Internal auditing, deviations, Out Of Specification (OOS) and complaint handlingPerforming trend analysis and using effective RCA toolsHow to use of statistical methodologies when performing Root Cause AnalysisCAPA and the linkage to effective management review and annual product reviewsStep-by-step basics on how to build your own comprehensive CAPA programMost important: Review of the real benefits of an effective CAPA system