Outsourced Operations: Managing ContractorsResponsibility of the Contract Giver / Contract Acceptor

בהדרכת: גב' קרן גינסבורי
מק"ט: 20864
גרסה להדפסה

שתף קולגה:

NEW: In January 2020, EMA issued a 31 page, draft reflection paper on GMP and Marketing Authorisation Holders (MAHs).  The document emphasizes the responsibility of the Contract Giver.  What is the QP signing when they release a batch, and what level of raw data do they need to see to support that signature? “Virtual” company models are now common...המשך קריאה

NEW: In January 2020, EMA issued a 31 page, draft reflection paper on GMP and Marketing Authorisation Holders (MAHs).  The document emphasizes the responsibility of the Contract Giver.  What is the QP signing when they release a batch, and what level of raw data do they need to see to support that signature?
“Virtual” company models are now common – no manufacturing, testing or even handling of drug products – all processes are outsourced but the company QP must release the batch.

Importers, and license-holders, even traditional manufacturing companies, in an increasing drive for efficiency, are outsourcing more activities.  The planning, coordination and oversight in order to ensure ongoing GMP / GDP compliance is complex.  This interactive workshop-style course, will look at process mapping, identifying CCPs (Critical Control Points) and assigning adequate resources to effectively oversee and manage processes.

סגור
תאריכים: 
  • 06/05/2020
  • 13/05/2020

מתעניינים? לחצו כאן

    מיקום הקורס: כפר המכביה, רמת גן
    משך הפעילות: 2 ימי לימוד מפוצלים ל 4 מפגשי Zoom
    שעות: 17:00 - 09:00
    נקודות זכות: 2
    שפת הקורס: עברית

    עלות הקורס המלאה: ₪5,850 + מע"מ
    ההרשמה המוזלת נסגרה
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    יש לך שאלה? יש לנו את כל התשובות

    מה תכני הקורס?

    • Regulatory framework:
      • Recent inspection / audit findings, warning letters
      • EMA 2020 Reflection Paper: MAH Responsibilities
      • GMPs, ICH Q10, FDA guidance on quality agreements
      • Process Mapping and identifying Critical Control Points
    • Process Mapping: a pre-requisite to audit and MSA
    • Auditing contractors and acceptance (or not) of the quality system
    • CAPA oversight – before and after MSA
    • Business Agreement (MSA) vs Quality Agreement / Technical Contract
    • Ongoing monitoring and oversight
    • Defining and Managing Communication: It will not “just happen”
    • The role of the virtual company
    • Remote data review in summary reports and COAs: QP responsibility
    • The role of a mediator in dispute resolution
    • PQRs and CPV; stability data and FARs
    • Complaints, Product Quality Defects and Returns / Recalls management
    • Massaging the relationship

    למי זה מתאים?

    This course is suitable for anyone working in the pharmaceutical industry:

    • An outsourced service provider
      CMOs, Contract Testing Facility, contract storage, contract clinical services provider, calibration and validation service providers etc.
    • Anyone using the services of outsourced providers
      Company General Managers, Managing Directors (GMPs and ICH Q10 focusing on management leadership), QPs, Quality Assurance, Quality Control and other quality professionals, Operations and Production managers, Research and Development, persons working in technology transfer, personnel working in pharmaceutical Active substance and finished product manufacture as well as distributors, brokers, wholesale dealers and anyone involved in the manufacture of starting materials, Active Substances, finished pharmaceuticals or involved in the handling, processing or sale or administration of any of these.  Persons involved in clinical trials and manufacture and administration of Investigational Medicinal Products will also find the course very useful.

    מה אקבל מכך בפועל?

    Participants will come away from this course with an understanding of: outsourcing and the difference between using a contractor to performing activities in-house using company personnel.  The workshop will look at resource realignment.  How much independence can a contractor be allowed and what does “review of results / reports” mean in terms of time and depth of review.
    At the end of the2-day participants will understand:

    • How to initiate a relationship
    • The role of audit
    • The role of the quality agreement
    • Ongoing oversight

    מי מעביר את הקורס?

    קרן גינסבורי
    קרן גינסבורי, M. Sc. B. Pharm. MR PharmS – בעלת
    קרא עוד

    הוספת תגובה

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