2-day In-person Seminar

Root Cause Analysis: Foundation of Investigations and CAPA


May 16th & 17th, 2018

Time: 9:00 AM to 5:00 PM

Philadelphia

Venue: DoubleTree by Hilton Philadelphia Airport


Director : David R. Dills

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,495.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $4,485.00
      $7,475.00 You Save: $2,990.00 (40%)*

  Register for 10 attendees   Price: $8,222.00
      $14,950.00 You Save: $6,728.00 (45%)*
Course "Root Cause Analysis: Foundation of Investigations and CAPA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Why you should attend:

  • What do the regulations say?
  • Four Phases of RCA
  • Promote the ability to provide problem-solving support in situations where one is not an expert in the process or technology involved
  • Expand the range of tools available for analysis of problem situations
  • Apply a variety of tools to narrow down the possible causes of a problem
  • Learn how to investigate serious and complex incidents and events
  • Learn the importance of near-miss investigations, incident classification, and data trending
  • Learn how to identify root causes (not just causal factors) using proven techniques
  • A robust investigation and root cause analysis process, as well as, basic root cause analysis tools that can transfer to any company
  • Understanding of the major cause categories that can affect your processes - and which categories tend to be the most overused and underused
  • How to identify whether you’re finding the direct or the root cause of a problem
  • The ability to identify the true cause of an issue and, as a result, identify and implement more effective CAPAs
  • Tips for implementing a root cause analysis training program at your facility - and what support is required for the process to work once people are trained
  • Apply performance management concepts in case studies with a focus on prevention and issues management
  • Recognize components of effective corrective action planning and documentation
  • Identify examples of corrective action planning for different site noncompliance case scenarios
  • Discuss successful preventive action planning and implementation
  • Develop, establish, implement, and maintain effective root cause analysis and CAPA procedures and other documentation
  • Discussions on proper CAPA system maintenance, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan
  • Attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
  • Challenges and possible solutions will be discussed, and examples will demonstrate how the requirements can be put into practice
  • Review and discuss pain points, challenges and solutions
  • Are you in compliance with the FDA Corrective and Preventive Action (CAPA) requirements?
  • Do you know how to identify root cause and how to close out your investigation?
  • Understand that the cost of regulatory noncompliance remediation is significantly greater than the cost of compliance
  • Leave the seminar with a better understanding of structured root cause analysis, effective investigational techniques and ensuring that the CAPA system is well established and maintained

Who will benefit:

This seminar will be of benefit to anyone working in a GMP regulated environment on global or domestic scale within the pharmaceutical and medical device industry. This includes quality, validation, engineering, manufacturing, and management personnel from sponsors and contract manufacturers (CMO) alike. This is anyone who wants to improve their ability to solve recurring problems should attend this training. Additionally, those who are actively involved in performing, overseeing, auditing, or managing investigations will find this course extremely beneficial.
  • Quality Managers
  • Auditors
  • Operations and Manufacturing Personnel
  • Validation
  • Engineers
  • Product/Process Development
  • Principal Investigators, Site Research Directors and Coordinators
  • Quality Assurance Staff
  • Regulatory Managers and Professionals
  • Compliance Managers and Professionals

Day 1 Schedule


Lecture 1:

Regulatory Expectations for Investigations

  • Background and History
  • FDA Regulations and Regulatory and Compliance Aspects
  • Regulatory Expectations for Investigations
  • FDA (21 CFR and Guidance Documents)
  • EU references
  • ICH
  • FDA 483s and Warning Letters
  • CAPA and RCA: root cause investigations follow steps such as identify the problem; evaluate its magnitude, which includes assessing risk; investigate and assign responsibility; and analyze and document the root cause of the problem.

Lecture 2:

What is RCA and Typical Problems

  • Why most problem-solving models don’t get to the root cause, and a solution
  • How analytical and creative thinking must be both separated and integrated
  • Difference between content and process thinking

Lecture 3:

Investigation Process Overview

  • Purpose, basics and sources (types and categories) of investigations
  • Elements of a thorough investigation process (Discovery through
  • Closeout)
  • Classification levels
  • Investigation planning, action items and documentation
  • Company culture

Lecture 4:

Skills and Tools of an Effective Investigator

  • Characteristics and techniques
  • Reading and documentation practices
  • Technical writing

Lecture 5:

(Re) Introduction to Root Cause Analysis (RCA)

  • Principles of root cause analysis
  • Why root cause analysis is difficult
  • Methodology of root cause analysis
STEP 1 - Problem Definition
  • How to ensure that the right problem is being worked on
  • Tools and filters for priority setting
  • Developing a clear and sufficient problem statement (includes practice)
STEP 2 - Understanding the Process
  • How every problem is a process failure
  • How diagrams can set boundaries and define interrelationships
  • Using flowcharts to drill down into the right part of the process (includes practice)
STEP 3 - Identifying Possible Causes
  • Multiple ways to identify possible causes
  • Options for selecting or eliminating causes
  • Logic trees as a cause and effect diagram and other tools for investigations

Lecture 6:

Defining the Deviation

  • The problem statement
  • Active listening and interviewing
  • Process mapping
  • Brainstorming tools
  • "Is/Is Not" technique
FDA Enforcement Actions and Industry Trends

Day 2 Schedule


Lecture 1:

Identifying Root Cause

  • 5 Whys
  • Relations Diagram
  • Ishikawa diagrams (Fishbone)
  • Fault Tree Analysis vs. Failure Modes and Effects Analyses (FMEA)
  • Challenges
STEP 4 - Data Collection
  • Population versus sampling; options for sampling
  • Check sheets, graphs, and tables for discrete data collection
  • Surveys, interviews, and field observation for opinions or less precise data
STEP 5 - Data Analysis
  • Tools for discrete data analysis (run charts, histograms, pareto diagram, modified scatter diagram, pivot tables)
  • Tools for softer type data (affinity diagram, relationship digraph)
  • Integrative data analysis tools

Lecture 2:

Corrective and Preventive Actions (CAPA)

  • What is the CAPA System
  • Definition and regulatory interpretation
  • Identifying and writing of corrective actions
  • Abuses of the CAPA system
  • Discuss robustness and effectiveness review

Lecture 3:

Management of the Investigation

  • Members of the Investigation Team
  • CAPA management/team

Lecture 4:

Members of the Investigation Team

  • Culture
  • Compliant document extensions and interim reports (justification)
  • Management communication and notification
  • Metrics and trending
  • Interim controls, timetables and other reports
  • Policy and Standard Operating Procedures
  • Escalation action assessment
  • Common barriers and solutions
  • Investigator training

Lecture 5:

Consulting Case Study Practice - Incident/Events

  • Participants role play consulting with instructor on a problem
  • Review of key learning points

Lecture 6:

Case Study Practice

  • Practice on a project relevant to participants’ organization
FDA Enforcement Actions and Trends
Lecture 7:

Interactive Exercises and Discussions

  • Case studies
  • Identification of noncompliance and questions to ask to determine the root cause
  • Identification of necessary corrective actions and preventive actions

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David R. Dills

Global Regulatory Affairs & Compliance Consultant and President, NovaQual

David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities, by medical device manufacturers and consultancies, including a globally recognized CRO, and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA's, warning letters,483 observations, and customer generated compliance events. He prepares for and conducts QS and regulatory audits He is currently acting and interim President at NovaQual LLC.

He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing responses to AI's/deficiency letters, Supplements, Amendments, acting U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.

Mr. Dills has a strong background in the interpretation and applicabilityofFDA regulations,including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activitiesfor the registration and approval process andworking with Agencies in Asia Pacific, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for reduction of regulatory compliance risk for companies.

Directs and leads efforts for PM support and consultative services on behalf of manufacturers and subcontracted bythird-partyconsultancies and provides services involving all phases ofthe product development, submission, and commercialization process from premarketing to postmarketing; retained as U.S. Agent for international pharma and device clients; conducting supplier and QS audits/assessments; UDI compliance strategies; establishment registration and listing; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting GxP audits and preparing CAP/remediation plans; compliance engineering support; support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting, Postmarketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO13485 registration and CEMark; andmulti-countryproduct registrations and licensing.

Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides guidance and clarity on regulatory requirements, prepares and/or reviews submissions [e.g., NDA, ANDA, 510(k), PMA, IDE, CTD/CMC and BLA], including design dossiers and technical files, and other applications for Asia Pacific, The Americas and EU. Directs and leads efforts in establishing and retooling QA systems with emphasis on preventing the design, manufacture, and shipment of defective product; provide compliance engineering support; and lead efforts for GxP Strategic Compliance.

Mr. Dills manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; RA/RC oversight and governance; design controls; CAPA/investigations; GxP training; software and process validation with compliance oversight; supplier management; interfaces with FDA and other Agencies on the regulatory landscape; compliance with MDD/IVDD Directives and Technical File/Design Dossier and CE Mark requirements; conducts MDSAP training; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure.

He also develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance. He conducts Compliance, Governance, Assessments and Agency Mock Inspections; assist companies during FDA and other regulatory authorities' inspections and with post-inspection correspondence and meetings, involved in the product life cycle and commercialization process and works effectively across all functions for overall corporate compliance to support a company's goals and strategies.

Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory precedents and new legislation; understands the competitive landscape; develops the business and regulatory approach; conductspersuasive communication with regulatoryauthorities;executes an effective path to approval; assists with GxP compliance strategies, effectively coordinates development in multiple markets; selects appropriate testing and manufacturing suppliers; and strives for overall corporate compliance withregulationsin The Americas, EMEA and Asia Pacific.

He provides direction on understanding the regulatory landscape for the product and provides a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities.

Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals.

Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills' academic degrees include Environmental Science andBiology.Heis aformer Chair and Co- Chair of ASQ's Section 1506 and associated with the BiomedicalDivision,RAPS,AdvaMed, PDA, ISPE, and other industry working groups.

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