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Instructor : Jeff Kasoff
Product Id : 30992PACK

Overview: Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.

Areas Covered in the Session:
  • Documents Used by FDA Inspectors
  • Investigations Operations Manual (IOM)
    • CAPA Implications
    • Recommended Methods of Compliance for each Requirement
  • CPG Manual 7382.845
    • CAPA Implications
    • Recommended Methods of Compliance for each Requirement
  • QSIT Manual
    • Description of each CAPA Inspectional Objective
    • Recommended Methods of Compliance

Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device,
Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
  • QA management
  • CAPA coordinator
  • Regulatory Affairs management
  • Executive management
  • Consultants
  • Quality System Auditors

Instructor : David R Dills
Product Id : 30992PACK

Overview: CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.

Industry is now using various risk-based approaches and tools to set-up, deploy and maintain their CAPA programs to help with the decision making process. Understand the emphasis on analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems...and the use of appropriate statistical methodology where necessary to detect recurring quality problems.

This session provides an overview on identifying recommended practices to improve, streamline, refine, retool…and develop, deploy and maintain a viable and sustainable CAPA system. Learn that a well written policy and procedure on setting up and maintaining your system is just the first part of the process…now you need to monitor your system because CAPA is your immune system and will determine how healthy or unhealthy or business site is. Learn some of the new practices being used on how to conduct the CAPA investigation and the use these tools.

Areas Covered in the Session:
  • How to use FMEA effectively and calculating Risk Priority Numbers: How to Use the Criteria
  • How to facilitate a product complaint investigation as part of your CAPA program
  • What is a closed-loop investigation…cradle to grave approach
  • How to conduct an investigation using a well-written CAPA policy and procedure
  • Understand and comprehend what FDA is looking for in meeting minimum expectations…no band-aid solutions
  • Why risk assessment and risk-based approaches, FMEA, FTA, HACCP, etc., are now the expectation in terms of good business practice
  • Establish a priority system as related to major versus minor or high risk versus low risk classifications…to support your decisions
  • Develop and deploy escalation rules and criteria to facilitate decision-making process
  • Understand what it takes to conduct a “quality” investigation to ascertain the root cause
  • Review and discuss recent CAPA red flags and FDA enforcement actions

Who Will Benefit:This webinar will provide valuable assistance and guidance to all regulated companies that are preparing to use or are currently using risk-based tools for CAPA investigations and closing out investigations in a timely manner. The employees who will benefit include:
  • All levels of Management for all departments and those who desire a better understanding or a "refresh" overview
  • QA/QC/CAPA Coordinators/CAPA Specialists
  • Regulatory Affairs and Compliance
  • Engineering/Technical Services/Operations
  • Consultants

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

Instructor : Charles H. Paul
Product Id : 30992PACK

Overview: CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management. What does the CAPA system do for the organization? CAPA not only indicates the organization's ability to respond to problems that arise but also to proactively anticipate and prevent subsequent problems from arising.

This webinar highlights the various regulations governing CAPAs, how CAPAs are successfully initiated and managed, how CAPA is an integral part of the quality system, and how an effective failure investigation and root cause analysis is accomplished.

During this webinar, emphasis is placed on the application and practical aspects of the process to include its critical steps, CAPA timing, participants to the process, roles and functions, and the pitfalls associated with CAPA investigations. The content of the webinar will focus on the practical and how to best thoroughly accomplish an effective CAPA system. At the completion of this webinar, you will be able to:
  • Explain the purpose and function of CAPA.
  • Identify and explain the relevant CAPA regulations.
  • Define exception/deviation reporting and explain the process of executing the reporting process.
  • Explain and trace the CAPA flow from problem identification to resolution.
  • Explain the challenges and pitfalls of the CAPA process and how they are overcome.
  • Explain CAPA's role in risk mitigation.
  • Explain how root cause analysis is executed.

Why should you Attend: It is always about success not failures…right? But in the life sciences we must address failures as well. Complaints and product issues must be handled expeditiously according to regulation or we will suffer the wrath of the FDA.

Regulatory audits and FDA 483 regulatory observations are the two events that are a constant worry for managers in regulatory industries. In terms of the FDA, from 2012 to 2016, the FDA has increased the number of warning letters issued by over 1200%. This is the primary reason that understanding CAPA and having a comprehensive CAPA system is critical to maintaining regulatory compliance. A CAPA system can help to identify problems before they become critical, can go a long way in the development of positive relationships with regulatory agencies by instilling confidence in your company's ability to identify and solve problems quickly and effectively, and further that confidence by convincing regulatory bodies and clients that identified problems have been resolved.

Following the guidance provided in this webinar will help to reduce nonconformance to procedures, improve the quality of the work that you do, and significantly minimize customer complaints.

Areas Covered in the Session:
  • CAPA defined
  • CAPA relevant regulations
  • Exception/deviation reporting
  • CAPA process flow
  • CAPA process steps explained
  • Challenges and pitfalls of CAPA's
  • CAPA and risk mitigation
  • Root Cause analysis

Who Will Benefit:
  • Associates
  • Scientists
  • Technicians
  • Supervisors
  • Managers
  • Directors
  • Scientists

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