Inspection Readiness Workshop: From Site Preparation to Successful Execution (E04)

21-22 February (CANCELLED) CEUs: 1.2

Would you know what to do if a regulatory body such as (FDA (CDER, CBER, CDRH, CVM), EMA, CFIA, PMA, etc.) or notified group showed up at your door? This two-day workshop provides you tools to prepare your organization for a regulatory inspection, and a chance to practice these skills in a safe and mentoring environment. We have all heard the adage “fail to plan, plan to fail,” and in no area is this more relevant than inspection readiness. This two-day, practical interactive workshop will prepare you to plan for inspections efficiently (without stressing you or your staff), accurately, and be able to execute them effectively by knowing what to expect and how to best respond.

Topics include:

• Understanding the purpose of the inspection and your regulatory filing
• Conducting a Quality Systems Gap Assessment for inspection preparation
• Knowing the expectations of the agencies based on the newly implemented FDA Compliance Program Guidance Manual (CPGM)
• Inspection logistics and site preparations
• Preparing computer and automated systems for regulatory review
• Special considerations for laboratories and process equipment
• Practice Interview techniques, what to do and what not to do when conducting a site tour and how to give an effective software demonstration

How You Will Benefit

• Comprehensively understand a site inspection readiness program
• Understand the regulatory authorities’ audit processes and the purpose of an inspection
• Utilize the tools needed to accomplish tasks related to inspection readiness
• Distinguish specific roles and responsibilities during an audit
• Evaluate the inspection intricacies associated with facilities, laboratories, utilities, and process equipment
• Establish yourself as an expert in your functional area
• Formulate effective responses to various types of questioning used by the FDA and other regulators
• Guide auditors to focus on your quality system’s strengths instead of weaknesses

Who Should Attend

Professionals from quality assurance, quality control, engineering, regulatory compliance, quality systems, validation, IT, laboratory, as well as manufacturing supervisors, and area leaders/managers

Leaders

Speakers

• Jeff Campie, USA
• Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
• Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
• Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
• Edwin Melendez, Principle Consultant, Parexel, USA
• Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
• Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
• Julian Wilkins, Vice President, PharmaConsult US Inc, USA
• Paul Wreglesworth, Independent Consultant, United Kingdom