Preparation for FDA and EU Regulatory Inspections – 2018 Workshop

2-Day In-Person Seminar, from COMPLIANCE TRAININGS (Code – SEM9037)

Preparation for FDA and EU Regulatory Inspections

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             Somerset House Consultants

    September 27 – 28, 2018

      Zürich, ZH, Switzerland

Seminar DescriptionAgendaSpeakerPricingVenue
Regulatory authority GMP & GDP inspections are becoming more rigorous and more companies are receiving Warning Letters. This seminar will consider the powers of the EU & FDA inspectors, how to prepare for an inspection to ensure a successful outcome, and how to respond to inspection findings.

You will learn how to prepare for and what is the appropriate conduct during Inspections. Acquire the suitable skills necessary for responding to inspector’s questions. Descriptions of what records you have to provide and what records you should not provide. Learn how to write a procedure for preparing for FDA and other regulatory agency inspections.

The importance of data integrity and control of electronic records, with particular regards for recent problems with Indian API manufacturers. A comprehensive review of having and following written laboratory investigation procedures. Providing and maintaining adequate audit trails for traceability to your original data.

The seminar will be interactive, to allow delegates to discuss examples from their own inspection experience, and will also include practical exercises in making presentations to inspectors and compiling inspection responses.

Learning Objectives:

  • Gain understanding of the legislation behind regulatory inspections and the different types of inspection
  • Understand the requirements for an effective Quality Management System
  • Gain understanding of what inspectors are looking for during an inspection
  • Learn how to prepare for a scheduled inspection
  • Understand what to look for in a pre-audit self-inspection
  • Identify pitfalls and errors during an inspection
  • Understand what to say, how to say it, what you should NOT say
  • Learn how to respond to deficiencies during an inspection and the follow-up CAPA
Who Should Attend
  • Quality Assurance Departments
  • Quality Control Departments
  • Manufacturing Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • API Manufacturers
  • Production Departments
  • Documentation Departments
  • Warehousing
  • Supply Chain / Outsourcing
  • Contract Manufacturing Organizations
  • Contract Testing Laboratories
  • Internal Auditors
  • DAY 1 :

    Regulatory & legal basis for GMP & GDP Inspections

    • Development of global and EU rules and regulations
    • EU & FDA GMP requirements
    • Types of inspection & competent authority expectations
    • Examples of recent regulatory inspection findings

    Quality Management Systems

    • Characteristics of a successful QMS
    • Overview of ICH Q10 (Quality Management Systems) and Q9 (Quality Risk Management) guidelines
    • FDA ‘Six Systems’ Approach to Quality Management
    • Data integrity
    • Handling changes & deviations
    • Quality by Design
    • Senior management responsibilities in a compliant QMS

    Preparation for an Inspection

    • How to write an SOP for Inspections
    • Pre-inspection internal audit
    • Preparing the site and meeting room
    • Assembling documentation
    • Site Master File
    • Quality Manual
    • Product Quality Reviews
    • Effective SOP’s
    • Training records
    • Allotting audit team roles and responsibilities
    • Contacting the inspector

    Practical Exercise
    Delegates will be provided with details of pharmaceutical manufacturing and distribution sites which have been notified about a forthcoming regulatory authority inspection. You will formulate an action plan to make the facility ‘inspection ready’ and ensure relevant staff and documentation will be available for the inspector.

    DAY 2 :

    Regulatory Authority Inspections

    • Inspection team
    • Receiving the inspector – first impressions count!
    • Opening presentation
    • Facility tour
    • Answering inspector’s questions
    • Managing the audit room
    • Document review
    • Inspection do’s and don’ts
    • Closing meeting

    Inspection Follow-up

    • EU post-inspection letter
    • Critical, Major & Other deficiencies
    • FDA 483’s
    • Formulating the response

    Further Regulatory Actions

    • EU Compliance Management process
    • FDA Warning Letter

    Practical Exercise
    Delegates will be presented with a series of findings from a regulatory authority inspection. You will look at the findings and work out priorities, devise root cause analyses and provide detailed corrective actions.

    Robert Haslam

    Managing Director, Somerset House Consultants

    Robert Haslam is a pharmaceutical industry VP with over forty years of experience in Quality Assurance, Production, Development, Clinical Trials and Regulatory Affairs gained in multinational and start-up companies. He is the Managing Director of a consultancy providing quality assurance, manufacturing, development and training support to pharmaceutical companies worldwide. He is an EU ‘Qualified Person’ for marketed and investigational products, including steriles and non-steriles, generics, biopharmaceuticals, herbals. He is also an ISO-qualified Lead Auditor; experienced in EU & FDA Good Manufacturing Practice.

    He has extensive experience in GMP audits of drug substance, drug product and Investigational Medicinal Product manufacturers; outsourced activities; supply chain risk management. He has a successful track record of strategic management, facility qualification, designing and implementing quality systems, managing quality remediation programs, product development and outsourcing. He has designed and delivered bespoke GMP training courses to companies worldwide. Expert witness in litigation involving GMP compliance.

    For Single Delegate – $ 1200 (Save $ 300 on Early Bird Discount)
    Regular Price – $ 1500

    Group of 3 Delegates – Get 10% Discount (Save $ 1260)
    Group of 5 Delegates – Get 20% Discount (Save $ 2700)

    Early bird seats are limited and based on first-come, first-serve.

    For discounts on multiple registrations, contact customer care at +1-416-915-4458


    Payment Options

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    • Once the payment is completed, you will be receiving a Form to fill up the Delegates Information
    • An electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date.
    • Please bring the respective passes to the event venue.

    Pay by Wire:

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    By Check:

    • Pay your check to (payee name) “FutureCorp Consulting Inc” our parent company
    • Please send the Scanned copy of the check to
    • Mail the check to:
      FutureCorp Consulting Inc
      5939, Candlebrook Ct.,
      Mississauga, ON L5V 2V5,
    • Once we receive the check, you will be receiving a Form to fill up the Delegates Information
    • After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.

    Hilton Zurich Airport

    Zurich, Switzerland | September 27 – 28, 2018

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