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Outsourced Operations: Managing Contractors (including Quality Agreements)
With the increasing drive for efficiency, companies are outsourcing ever more activities. The planning, coordination and oversight in order to ensure ongoing GMP / GDP compliance is complex. This interactive two day course will look at process mapping, identifying CCPs (Critical Control Points) and assigning adequate resources to effectively oversee and manage the CCPs.
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Issues to be covered
The workshop will address the following topics:
- Regulatory framework: GMPs, ICH Q10, FDA guidance on quality agreements and inspectional findings related to use of contractors
- Process Mapping and identifying Critical Control Points
- Auditing contractors and acceptance (or not) of the quality system
- CAPA oversight – before and after MSA
- Business Agreement (MSA) vs Quality Agreement / Contract
- Ongoing oversight
- Communication
- The role of the virtual company
- The role of a mediator in dispute resolution
- Managing 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 the two days participants will understand how to initiate a relationship, the role of audit, the role of the quality agreement and ongoing oversight.
About The Lecturer
Karen Taylor (Ginsbury)
Karen Ginsbury, CEO of PCI Pharmaceutical Consulting Israel Ltd. Karen
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