Description
Taking the foundation principles of lean thinking, coupled with years of effective quality system development experience, this webinar presents a practical approach to quality system continuous improvement through value stream mapping. This approach incorporates key value factors of compliance, cycle-time and user friendliness and techniques for enhancing the efficiency and usefulness of various quality systems from Corrective Action/Preventive Action (CAPA) and complaints to design control and validation. Participants with process development skills and a working knowledge of quality systems will benefit.
How You Will Benefit
At the conclusion of this session, participants will be able to:

• Understand the value and the process development of a lean quality system
• Use value stream mapping tools for quality system development
• Incorporate the factors of compliance, user friendliness, and cycle-time in the value stream model
• Apply the principles of lean to continuous improvement work across the quality system to increase efficiency and effectiveness within the barriers of regulatory compliance requirements

Topics Include

• Quality system development key principles and value stream mapping
• Identification of key regulatory requirements; building these into the quality system model
• Development of assessment tools to determine current state compliance, user friendliness, and cycle-time
• Developing a meaningful value ratio from weighted compliance, user friendliness, and cycle-time factors
• Case study

Who Should Participate
Professionals from quality, compliance, engineering, and regulatory.

Description
Preparing for an inspection by FDA or other regulatory authorities requires the resources and interaction of every department in your company. You and every member of your team can benefit by becoming acquainted with the overall inspection readiness process and preparing for the potential of being interviewed by an auditor. This instructive and useful webinar provides an overview of the inspection readiness process, from internal evaluation of your quality systems to the logistics of the audit itself, with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.
How You Will Benefit
At the conclusion of this session, participants will be able to:

• Understand the tools needed to accomplish tasks related to inspection readiness
• Describe regulatory authorities’ audit processes
• Effectively fulfill your role and responsibility during an audit
• Use techniques to establish yourself as an expert in your functional area
• Use techniques to formulate responses to various types of questioning used by FDA and other regulators
• Apply strategies for guiding auditors to your quality system’s strengths instead of weaknesses

Topics Include

• What is Inspection Readiness?
• Project planning and charter
• Management Sponsorship
• Evaluation Phase
• Remediation Phase
• Mock Audits
• Quality System mapping
• Key quality system identification
• Stakeholder surveys

• Mapping documentation for key quality systems
• Creating a vulnerability list
• Creating a Subject Matter Expert (SME) roster
• Command Central: The “room behind the audit room!”

Who Should Participate
Professionals from quality, compliance, engineering, and regulatory.