Outsourcing and Virtual Operations Flashcards
What is outsourcing?
Goods or services from an outside or foreign supplier, especially in place of an internal source.
Examples include CMO, CRO, CMDO, Sales, etc.
What are virtual teams?
Groups of people with a shared goal who fulfill their roles with little or no time meeting face to face.
Define virtual operations.
A virtual business conducts all or most of its business via the internet and does not have physical premises to interact with customers face-to-face.
What functions are often outsourced in virtual pharmaceutical companies?
- Manufacturing
- Product development
- Clinical
- Marketing
- Sales
- Distribution
What is a team charter?
A document that records the team values, agreements, and operating guidelines, establishing clear expectations regarding acceptable behavior by project team members.
What does a team charter include?
- Team values
- Communication guidelines
- Decision-making criteria and process
- Conflict resolution process
- Meeting guidelines
- Team agreements
How does the number of stakeholders affect communication channels?
As the number of stakeholders increases, the number of communication channels increases, which increases the complexity of the project.
What are the components of communication management?
- Plan Communications Management
- Manage Communications
- Monitor Communications
What is the importance of a robust communication plan?
It ensures communications are efficient and effective.
What does the Project Compliance Plan evaluate?
- Government Regulations
- Product Quality
- Risk Tolerance
- Corporate Policies
What are the procurement processes?
- Plan Procurements
- Conduct Procurements
- Control Procurements
What types of procurement contracts are there?
- Fixed-price contracts
- Cost-reimbursable contracts
- Time and Material contracts
What is a Firm Fixed Price (FFP) contract?
Price for goods is set at the outset and not subject to change unless the scope of work changes.
What distinguishes a Cost Plus Incentive Fee (CPIF) contract?
It includes actual cost plus an adjusted fee based on agreed-upon performance criteria, with savings or cost overruns shared between seller and buyer.
What is the purpose of vendor evaluation in outsourcing?
To ensure that any function that is outsourced can be executed as intended.
What is required by regulators for vendor qualification?
The manufacturer must perform supplier and vendor qualifications per current FDA regulations.
What are some methods for evaluating suppliers?
- Inspection and Audits
- Documentation or desk audits
- On-site or for-cause audits
True or False: The entity holding the license approval to market a product has no obligation regarding outsourced functions.
False
Fill in the blank: A virtual business does not have _______ to interact with customers face-to-face.
[physical premises]
