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תיפעול של מיקור חוץ: ניהול קבלני משנהאחריות שני הצדדים בהסכם
Outsourced Operations: Managing Contractors
Responsibility of the Contract Giver / Contract Acceptor

Conducted by: גב' קרן גינסבורי
SKU: 20864
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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...Continue reading

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.

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Dates: 
  • 06/05/2020
  • 13/05/2020
Course location: כפר המכביה, רמת גן
Duration: 4-Days Course
Hours: 09:00 - 17:00
Credits: 2
Course Language: עברית

Course price: ₪5,850 Including VAT
Early registration is Closed
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Issues to be covered

  • 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

Who should attend

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.

Benefits to the Participants

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

About The Lecturer

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