Operations Management for
Pharmaceutical, Biotech, and Medical Device
Manufacturing
Supply Chain
Kaizen / Lean Process Improvement
Supplier Management
Operations Management Overview
The Pharmaceutical, Biotech, and Medical Device Operations Management involves long term impact on the organization. The management needs to keep in their mind a number of key factors such as
- Demand and supply balance
- Production cost
- Lead time
- Inventory
- Resource allocation
- Capital asset management
- Procurement
- Efficiency
- Tracking and resolving quality issues
The Medial Device Manufacturing Process is regulated by FDA 21 CFR 820.70 Production and Process Controls and must be compliant wth GMP. Under this highly regulated environment, it takes an effort to establish the balance of efficiency and compliance. During Design Transfer (21 CFR 820.30 (h)) phase, Operations plays a big role for development program. The Operations need to provide additional workload to support PMO.
Our experienced experts assess your current process closely and provide a strategy to comply FDA regulatory requirements and find the area of improvement, reducing cost and labor while improving the efficiency. Alectena offers a Pharmaceutical, Biotech, and Medical Device Manufacturing Comprehensive Potential Assessment, resulting our clients to achieve further operational efficiency. We practice our proprietary qualitative and quantitative methods to uncover potentials of improvement for Pharmaceutical, Biotech, and Medical Device Operations Management.
Our Approach
- Kaizen: Comprehensive Kaizen (continuous improvement) framework introduction, instantly influences employees’ mindset
- Process Effectiveness: Assessment of yield, quality, ergonomics and speed of each manufacturing step
- Lean Six Sigma methodology: ways to minimize Muda (waste), Mura (unevenness), Muri (overburdening) to ensure 5S environment and achieve high repeatability and standardized processes
- Stabilizing Supply Chain: Reduces a number of logistics routes and shipping, resulting cost reduction for procurement
- Key performance indicators: We identify undiscovered KPIs and associate them with the organizational goals
- Inventory reduction: The We analyze the cost and area of overstocking and reduce unnecessary inventory
- Customer service: Reduce the overproduction and eliminate the lack of on-time deliveries
Increase Your Pharmaceutical, Biotech, and Medical Device Operations Efficiency Today
At Glance
A Case Study
12%
Reduction in unit
manufacturing costs
8%
Reduction in inventory
6%
Reduction in cycle time
9+
Processes implemented for
ergonomic enhancement
Employee satisfaction