$699 – $2,289

Implementing an Effective CAPA System: cGMP, Root Cause Analysis (RCA), Inv...

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Taipei

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Taiwan, Province of China

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Description

One of the fundamental concepts of cGMP is that companies that manufacture or test medicines should have systems in place that ensure the safety, purity and efficacy of the marketed drugs. One of the pillars of this philosophy is that companies must be self-healing to maintain a State of Control; in other words, when a problem arises, that problem can be detected and subsequently corrected. The current expectation for US and EU regulators is that the Deviation/CAPA systems that are in place should be robust enough to Detect an event; put temporary measures in place to contain the problem; have a team of experts trained to investigate and determine root cause; then put a solution in place that stands the test of time.

Whether the event occurs with a patient in the market or on the shop floor or in the lab, the progression is always the same: Event Detection → Investigation → Root Cause Analysis → Testing of Root Cause → Development of Solution → Test & Implementation of a Solution → Verification that the Solution is Robust (Effective).With the advent of ICH-Q9, all of the above steps are required to be performed within the context of Risk Analysis and Impact Assessment.

US FDA has historically pegged “inadequate investigation” as one of the top 3 observations year on year. Inadequate Investigations and weak CAPAs are a straight path to receiving an Import Alert, Warning Letter and/or EU Non-compliance Report.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

A small investment to ensure the workforce is fully trained in Investigation and CAPA is the best insurance to avoid regulatory action that can have a negative market impact on the company and potentially huge cost for remediation.

In this two day workshop conference you will learn what global regulators expect for Investigation, Root Cause Analysis (RCA), Corrective Action and Preventative Action (CAPA), Risk Analysis and Impact Assessment. During the workshop we will analyze case studies and perform class activities to better understand both theory and some practical approaches to performing comprehensive investigations with robust CAPAs that are scientifically justifiable.

Learning Objectives:

Upon completing this course participants should:

  • Understand the history and expectations for global regulators for Investigation and CAPA
  • Understand the vocabulary of Investigation and CAPA
  • Understand the difference between the CAPA system and a CAPA
  • Understand how to reduce bias while improving the approach to Event Investigation (Deviation / OOS / Non-conformance / etc.)
  • Understand the difference and roles of both Risk Analysis and Impact Assessment in Investigation and CAPA
  • Learn about the tools of investigation and how to apply them
  • Learn what GMP transactional mapping is and how to apply it to investigation, risk assessment and RCA.
  • Learn the difference between the signals of an event and True Root Cause
  • Problem solving methods to help you asses select the best solution for the root cause
  • Develop successful CAPA implementation plans
  • Learn why the Justification for the CAPA is equally important as the solution itself
  • How to prepare and present the Investigation and CAPA program to investigators during an inspection
  • The many uses of CAPA beyond just closing deviations (CAPA as an Agent of Change)

Who will Benefit:

This course is designed for people throughout the GMP Operations. As deviations can occur anywhere within the GMP environment it is imperative that all personnel have some understanding of Investigation and the functions of CAPA. In addition, there also need to be some few select SMEs within the organization to guide with process / compliance knowledge as required. While it is the Quality Unit that owns the systems, it is operation personnel who are most familiar with the occurrence of events and have specific process knowledge to determine the potential source of the Root Cause.

In addition, as CAPA is a major Quality Management System, the Quality Unit Management has specific responsibility for making general improvements in their organization’s performance and presenting (reporting) the systems to the QMR, regulatory inspectors and soon to Regulatory Agencies as part of Quality Metrics requirements.

Following personnel will benefit from the course:

  • Executive Management and Senior Quality Managers
  • Quality Professionals
  • Regulatory Professionals
  • Compliance Professionals
  • Production Managers, Supervisors and Operators
  • Manufacturing Engineers
  • Warehouse Managers, Supervisors and Personnel
  • Calibration, Preventive Maintenance and Production Engineers
  • Process and Department Owners
  • Quality Engineers
  • Quality Auditors
  • Deviation & CAPA System Personnel
  • Designated Investigators and Process Improvement Personnel
Day 01(8:30 AM - 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • Introduction Investigation and CAPA
    • What is an Investigation?
    • What is a Correction?
    • What is a Corrective Action vs a Preventive Action?
    • Why are Investigation and CAPA important?
  • Regulatory requirements and the inspector’s expectations
    • The meaning of adulteration
    • History of the Deviation & CAPA System
    • Impact and cost of Poor Investigation and CAPA
    • Current Regulatory Thinking and 483s Data
    • Impact of Global Harmonization (ICH)
    • Future expectations
  • The Event Reporting & CAPA System
    • Why is discussing CAPA so hard?
    • Vocabulary of CAPA
    • Sequence of Investigation and CAPA
    • Commonalities for CAPA
    • Ideal CAPA System
  • Event Characterization
    • What is it
    • Bias in investigation and how to neutralize it
    • Signals and how to interpret them
    • Event Characterization Exercise
Day 02(8:30 AM - 4:30 PM)
  • Investigation
    • Data Mining
    • Tools of Investigation
    • GMP Transactional Mapping
  • Root Cause Analysis (RCA)
    • Analyzing Data
    • Signals and RCA
    • Null Hypothesis
    • DOE for turning on / off the problem
    • RCA Justification and Reporting
  • Risk Analysis and Impact Assessment
    • ICH-Q9 and why Risk is a requirement
    • Tools of Risk
    • Role of Impact Assessment
  • GMP Awareness Exercise
  • CAPA Planning & Execution
    • Root Cause and developing Corrective Actions or Preventive Actions
    • DOE’s and robust solutions
    • What will be our metrics for success? (Efficacy planning)
  • Case Study Exercises from Typical Real Life Problems
    • The Case of the Shop Floor Data Integrity Conspiracy!
    • Customer Compliant: Patient found a small Purple Tablet in a Bottle of large White Tablets
    • Media Fill Failure Investigation (Successful use of Transactional Mapping)
    Warford Reaney

    Warford Reaney
    Consultant and Mentor

    Mr. Reaney has over twenty-five years’ experience in building, developing and managing teams to solve complex technical, regulatory, compliance and business challenges. His broad knowledge includes serving in Executive and Quality Management for multi-national corporations, biopharma start-ups and established pharmaceutical enterprises. Years of direct hands on involvement provide specific abilities to assist life science companies who serve or are entering the US/EU markets to achieve their technical, quality, product and financial goals within a context of good science and FDA / EU compliance. His frequent interaction with the USFDA enables him to assist manufacturers to meet the most current regulatory expectations.

    Mr. Reaney has spent many years in India immersed in the diverse cultures and unique ways of business: As a teenager, he lived for several years with his parents in Hyderabad when his father worked for UNDP introducing technology for the nascent Indian Sponge Iron industry; after his university studies, he returned to India on a Fulbright Scholarship for two years; then in 2007, he and his wife moved to Indian and have been working with and mentoring Indian, US & EU companies who have operations in India and abroad for GMP manufacturing of API, OSD and Parenteral Formulations and for Biotech manufacturing.


    Please contact the event manager Marilyn below for the following:
    - Discounts for registering 5 or more participants.
    - If you company requires a price quotation.
    Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
    You can also contact us if you require a visa invitation letter, after ticket purchase.
    We can also provide a certificate of completion for this event if required.

    NO REFUNDS ALLOWED ON REGISTRATIONS
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