Regulatory Compliance Auditing for Pharma Manufacturers


2-Day In-Person Seminar, from COMPLIANCE TRAININGS (Code – SEM9060)

Regulatory Compliance Auditing for Pharma Manufacturers


   


      Joy McElroy

    Raleigh, NC, USA

 


    June 20 – 21, 2019

1 DELEGATE

3 DELEGATES

5 DELEGATES

$ 1100

(Save $ 300) 🛈

$ 990 / Delegate

(Save $ 1230) 🛈

$ 880 / Delegate

(Save $ 2600) 🛈

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Seminar DescriptionAgendaSpeakerPricingVenue
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Compliance auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.

This seminar is designed for people tasked with performing internal and external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.

Who Should Attend
  • Quality Management and Staff
  • Regulatory Affairs Management and Staff
  • Compliance Management and Staff
  • Manufacturing Management and Staff
  • Engineering Management and Staff
  • Operations Management and Staff
  • Production Management and Staff
  • Validation Management and Staff
  • Design Engineers
  • Process Owners
  • Documentation Departments
  • Quality Auditors

  • Learning Objectives:

    • Understand what a regulatory compliance audit is.
    • Understand the background and basics of regulatory compliance auditing.
    • Understand proper Auditor conduct.
      • Communication
      • Dress
      • Punctuality
      • Difficult situations
    • Learn the necessary skills for conducting audits.
    • Understand how to prepare and plan for a regulatory compliance audit.
    • Understand and know how to properly perform an audit.
      • Opening meeting
      • Touring the facility
      • Questions
      • Observations
      • Close out meeting
    • Understand the types of regulatory compliance audits
    • Learn proper questioning techniques
    • Understand proper audit observation classification
    • Learn to write an audit report
    • Understand conducting a follow up audit
    • Learn how to become Lead Auditor certified
      • ASQ Certification
      • ISO Certification
      • Medical Device Certification

    DAY 1 : (8:30 AM – 4:30 PM)

    Regulatory Compliance Auditing
    – Audit background and basics
    – Definitions
    – What is an Audit?

    Types of Regulatory Compliance Audits
    – Internal Audits
    – External Audits
          i) Supplier Audits
          ii) Distributor Audits
          iii) Due Diligence Audits

    Proper Auditor Conduct
    – Communication
    – Dress
    – Punctuality
    – Difficult Situations

    Skills for Conducting Regulatory Compliance Audits
    – Responsibilities
    – Knowledge
    – Techniques

    DAY 2 : (8:30 AM – 4:30 PM)

    Preparing and Planning for a Regulatory Compliance Audit

    Performing the Audit
    – Opening Meeting
    – Touring the facility
    – Questions
    – Observations
    – Close- Out Meeting

    Observation Classification
    – Minor
    – Major
    – Critical

    Writing an Audit Report
    – Time of delivery
    – Cover letter
    – Format of Report

    Conducting a Follow-up Audit

    Lead Auditor Certification Programs
    – ASQ
    – ISO
    – Medical Device


    Joy McElroy

    Principle Consultant at Maynard Consulting


    Joy McElroy offers over 15 years of experience as a consultant and over 20 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.
    PRICING OPTIONS
    For Single Delegate – $ 1100 (Save $ 300 on Early Bird Discount)
    Regular Price – $ 1400

    Get 10% Discount on Group of 3 Delegates – $ 990 / Delegate on Early Bird Offer (Save $ 1230)
    Get 20% Discount on Group of 5 Delegates – $ 880 / Delegate on Early Bird Offer (Save $ 2600)

    EARLY BIRD OFFERS CLOSES ON JUNE 6, 2019
     
     
     
     
    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

     
    REGISTER NOW


    Payment Options

    Register Online:

    • Make Secure Payment using Credit Card
    • Click on Register Now, and you will be redirected to Payment Options page.
    • Please choose your option (No. of delegates) from the drop down and click on Add to basket
    • Click on Proceed to Checkout on the Cart Page, and complete the registration.
    • 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:

    • Please contact our support to assist you with registration by Wire
    • Support Number: +1-416-915-4458
    • E-mail: info@webinarcompliance.com

    By Check:

    • Pay your check to (payee name) “FutureCorp Consulting Inc” our parent company
    • Please send the Scanned copy of the check to info@webinarcompliance.com
    • Mail the check to:
      FutureCorp Consulting Inc
      5939, Candlebrook Ct.,
      Mississauga, ON L5V 2V5,
      Canada
    • 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.
     

    DoubleTree by Hilton Hotel Raleigh-Durham Airport at Research Triangle Park

    Raleigh, NC, USA | June 20 – 21, 2019


    Call for Assistance: +1-416-915-4458   Register Now