INVESTIGATIONS BOOTCAMP IN PARTNERSHIP WITH NIBRT (NATIONAL INSTITUTE FOR BIO-PROCESSING RESEARCH AND TRAINING) Dates: January 29 th - 31 st, 2013 Time: 8:30am-5:30pm Venue: NIBRT, Dublin
Training Outline Day One "Investigations An IMB Perspective" Dr Kevin O Donnell, Market Compliance Manager, Irish Medicines Board Human Factors in the Management of Investigations: Dr Ginette M. Collazo Definition Human Errors Human behaviour How are we? Why do humans make mistakes? The systems: The conditions Root cause categories in human error investigations System Errors (that cause human errors) Human Error: o Procedures o Human Error Engineering o Training o Direct Supervision o Communication o Related to the individual (performance) Determine Root Cause The five - Why? Validation of Root Cause Prediction and Prevention Human Factor Concept Practice Days Two & Three Investigations in the Life Sciences sectors: Victor Sanchez and Magaly Aham What is an Investigation? Regulatory Requirements for Investigations Regulatory Citations linked to investigations Types of investigations (Manufacturing, Laboratory, Complaints, Exception Deviations) Elements of an investigation o Problem Statement o Scope o Risk assessment and impact analysis Presentation of tools o Trend analysis o Root Cause Analysis Root Cause Methodologies o CAPA o Effectiveness Checks Documenting Investigations
o o o Investigation Report Purpose and regulatory expectations Investigation Design Writing for your audience Executive Summary Supporting Documentation Monitoring the Quality System State Tracking and trending investigations Monitoring effectiveness checks Who should Attend this event Bio-Pharma & Medtech Project Managers/Leaders QA/QC Manufacturing Personnel Technical Services Planning/Procurement Supervisors/Managers Validation Engineering Information Technology Management Speaker Profile Dr Kevin O Donnell, Market Compliance Manager, Irish Medicines Board Kevin O Donnell, Ph.D., is Market Compliance Manager at the Irish Medicines Board (IMB) in Dublin, Ireland. He is responsible for a number of compliance-related and market-surveillance programs at IMB, such as the quality defect and recall program and the sampling and analysis market surveillance activities. Kevin is active at a European level in various regulatory activities and initiatives. He represents Ireland at the European Directorate for the Quality of Medicines in Strasbourg, France, in support of IMB s market surveillance testing activities. In 2007, he was elected to the Advisory Group for the General Official Medicines Control Laboratory Network and is also a member of the PIC/S Expert Circle on Quality Risk Management. Kevin worked in the pharmaceutical industry both in Ireland and in the United States before joining the IMB. Kevin obtained his chemistry degree from the University College Galway and both Masters and Ph.D. degrees from the Dublin Institute of Technology. His Ph.D. research related to the development of a practical quality risk management solution designed for use within good manufacturing practice (GMP)-related environments as an aid in facilitating compliance with the risk-based qualification, validation, and change control environments of the European Union (EU). That work resulted in several peer-reviewed research papers, one of which was awarded the Article of the Year award by the Journal of Validation Technology in 2007.
Resources Dr. Ginette M. Collazo has vast knowledge of GMP regulations and has worked in organizational reengineering and change management through the implementation of Strategies of Collective Behaviour Modification resulting in increased productivity. Ginette has specialized studies in Human Reliability and "The human factor in processes, human reliability and error prevention." She has been a speaker at: Interphex, American Institute for Chemical Engineers (AIChE), PR Psychologist Association, American Society for Quality (ASQ) and the Food and Drug Administration (FDA). Víctor Sánchez, a Summa Cum Laude Chemist, holds an MBA in Industrial Management from the InterAmerican University of Puerto Rico and is an MS candidate in Pharmaceutical Validation Technology from the Dublin Institute of Technology, Ireland. Victor is the President of European Operations for Pharma-Bio Serv LTD, a consulting service company which provides on-site support and training to FDA and EMA/EU regulated industries. Mr. Sánchez's expertise focuses in the areas of: manufacturing and quality operations, analytical method development and validation, analytical problem solving, process validation, GMP quality systems, and regulatory compliance. Prior to joining Pharma-Bio Serv in 2011, Victor spent seventeen (17) years in senior positions in quality and manufacturing operations, both in PR and Spain, directing efforts to roll over quality improvement and operational excellence programs. Víctor, based in Spain, teaches compliance disciplines, such as cleaning validation and QbD, in a Pharmaceutical Industry Master's Program from a recognized Spanish institution. He also trains groups in technical writing and root cause analysis. He is a PDA and ISPE active member. Magaly Aham has comprehensive management experience in Quality Assurance, Quality Systems, Compliance, Quality Control, Validation and Manufacturing Operations. She holds an outstanding career track record of improving compliance, quality, efficiency, efficacy and maximization of manpower through continuous process improvement. Magaly is the Director of Compliance and US Operations of Pharma-Bio Serv US. Her previous roles include Senior Manager Quality Systems, at MedImmune, Inc., Corporate Headquarters, MD; QC Associate Director at Wyeth Pharmaceuticals, PR; Manufacturing Operations Technical Assistance Manager at Schering, PR where she was appointed as API Consent Decree Leader with accomplishments including closing all API Consent Decree commitments a month before due date, exceeding the exceptional rating selected by the facility. At Schering she also held roles that included: Kepner-Tregoe Consent Decree Problem Analysis Leader, Change Control Manager, Regulatory Compliance Product Quality Revalidation Supervisor, Manufacturing Operations Process Support Specialist and Quality Assurance Specialist. Magaly holds a BS in Chemistry from the University of Puerto Rico and an MS in Bioscience and Regulatory Affairs from The Johns Hopkins University (to be completed 2012). Magaly is Kepner- Tregoe PSDM Certified, a Certified Trainer, ASQ Certified Quality Auditor (CQA) and a Licensed Chemist. She is a PDA active member.
Costs 1790 (+VAT) to include refreshments and lunch on 3 days 1590 (+VAT) for second and subsequent attendees Early Bird 1590 (+VAT) if confirmed by December 21 st 2012 Booking/Further Information Email rscanlan@pharmabioserv.com Phone 353 21 461 9034 www.nibrt.ie/trainingforindustry Payment Options Bank Transfer Cheque