Why You Need to Take This Training Course?
Why You Need to Take This Training Course?
With this Course will, Participants will learn :
Foundations & Compliance
- Define the core principles and various types of pharmaceutical contract manufacturing.
- Identify key regulatory requirements and ensure compliance with international and local health authority standards.
- Explain the essential elements of a Quality Management System (QMS) specifically within a contract manufacturing environment.
Commercial & Legal Frameworks
- Analyze the critical components of a Commercial Contract Manufacturing Agreement (CMA) through a detailed review of actual industry documents.
- Manage commercial negotiations and foster effective relationship management between owners and contract facilities.
- Apply Knowledge on a Medicinal Product Contract Manufacturing Agreement using a case study.
Operations & Risk Management
- Assess and mitigate risks within the contract manufacturing supply chain and logistics operations.
- Apply Operational Excellence and Lean Manufacturing principles to optimize production processes.
- Evaluate the product lifecycle management stages and the necessary knowledge transfer between parties to ensure sustained product quality.
What you'll learn
Participants will gain insights into:
The landscape and foundational concepts of pharmaceutical contract manufacturing.
The different models and partnership types that define outsourcing in the manufacturing space.
Key regulatory frameworks and compliance considerations relevant to third-party production.
How commercial agreements are structured and managed, including negotiation dynamics and relationship governance.
Real-world examples illustrating contractual arrangements and operational expectations between licensors and contract manufacturers.
The role and structure of quality management systems (QMS) in outsourced manufacturing environments.
Supply chain logistics and coordination strategies critical to ensuring seamless production and delivery.
Identifying and addressing operational and regulatory risks within contract manufacturing partnerships.
- Concepts supporting product lifecycle continuity and coordination across internal and external stakeholders.
- Duration: 15 Hrs. Three Days
- Time: 4.00 pm- 9.00 pm
- Prerequisite for this course: None
- Language: English
- Level: Management or any one interested
- Classroom & Virtual Training
- Price US $ 595
- Certificate Granted as Hard or Soft Copy
- Discount available for companies who send three or more participants
- Seats for this course: 12
- Virtual through google meet
- Classroom course at Upbeat office, hotel or at the customer premises
Registration Form
After Registration , You will be redirected to the PayPal or credit card (through PayPal gateway) payment
