Governance and Change Control according to GxP and GMP Requirements


2-Day In-Person Seminar, from COMPLIANCE TRAININGS (Code – SEM9026)

Governance and Change Control
According to GxP and GMP Requirements

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    KELLY THOMAS
             cGMP QA/QC Expert
 

    February 14 – 15, 2019

    Raleigh, NC, USA

Seminar DescriptionAgendaSpeakerPricingVenue
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP non-compliant changes occur. This Change Control training course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.


Learning Objectives:

  • Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records
  • Understand all the required components of a thorough Change Control record
  • Understand all the elements of effective Change Control management:
    • How to develop a cross-functional team to ensure proper evaluation, approval and implementation of proposed changes
    • Ensure changes do not negatively impact the business or established marketing authorization
    • How to incorporate a Quality risk based approach to evaluating proposed changes
    • Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
    • Understand what steps should be taken post implementation to confirm the objectives were achieved
Who Should Attend
  • Quality Assurance Department Management and Staff
  • Documentation Department Management and Staff
  • Manufacturing Department Management and Staff
  • Records Managers
  • Document Control Management and Staff
  • Compliance Department Management and Staff
  • Medical Affairs Management and Staff
  • IT/Software Department Management and Staff
  • Clinical Management and Staff
  • Laboratory Management and Staff
  • DAY 1 : (9 AM – 4 PM)

    Lecture 1: GxP/GMP Framework
    – Roles, Expectations, and its Consequences for the Regulated Industries

    Lecture 2: Information Governance
    – Procedures, Implementation and Document Management Systems
    – Social Media Management and Information Governance

    Lecture 3: Change Control Procedure
    – GxP/GMP and Change Control Procedure
    – Change Control Procedure Steps and Document Control

    Lecture 4: Change Control Procedure for Information Technology (IT) Systems
    – IT Change Control Procedure Steps

    DAY 2 : (9 AM – 4 PM)

    Lecture 1: Data Security
    – Data Security Implementation
    – E-Discovery Preparedness

    Lecture 2: Crisis Management
    – Understanding and Preparedness

    Lecture 3: Change Management and User Adoption
    – Change Management Strategy
    – User Adoption Strategy

    Kelly Thomas

    cGMP QA/QC Expert


    Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

    Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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

    Get 10% Discount on Group of 3 Delegates – $ 1080 / Delegate on Early Bird Offer (Save $ 1260)
    Get 20% Discount on Group of 5 Delegates – $ 960 / Delegate on Early Bird Offer (Save $ 2700)

    EARLY BIRD OFFERS CLOSES ON JANUARY 31, 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 | February 14 – 15, 2019


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