Here you can edit and choose your personal newsletter preferences and skip topics you’re not interested in.
(you can choose as many as you want!)
Outsourced Operations: Managing ContractorsResponsibility of the Contract Giver / Contract Acceptor
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...Continue reading
Have a question? We got all the answers
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
