Providing the Tools to Succeed
Customized Blister Packaging Training Courses
Montesino offers in-depth, on-site training for operators, maintenance and other production personnel to maximize performance and quality while optimizing packaging costs. Such training will develop in-house expertise in blister packaging materials and process conditions. Tailored to the materials and machines in use at the course site, the training includes understanding properties, process conditions and performance of blister packaging materials, machinery, and tooling.
The course consists of four modules:
- Materials and Specifications
- Machinery and Process Conditions
- Cavity Design and Tooling
- Practical Application: one half-day session on production machinery at the plant site
Montesino provides from one to three days of on-site training, presenting protocol for blister material specifications for review with the clients’ personnel. Using extensive visual aids to illustrate key concepts, the course is taught by our experts in the science of blister packaging. The course can be presented in English or Spanish.
Specific Course Objectives
- Establish a clear understanding of the three main components of blister packaging: materials, machinery/process conditions, and cavity design and tooling, applying the understanding to increase productivity and reliability in the packaging process.
- Develop an in-depth understanding of forming and lidding materials.
- Develop an in-depth understanding of process conditions and how they impact thermoforming/barrier.
- Develop a trouble-shooting guide to determine root causes of problems with blister packaging.
- Propose and review new protocols and specifications for blister packaging materials, including appropriate testing methodologies.
This course is fully customizable to address specific concerns. Please contact us for an in-house quote.
Learn the Fundamentals of Type III Drug Master Files (DMFs)
Properly submitted and well-maintained packaging supplier DMFs are essential to a smooth NDA process. We don’t want to see FDA deficiency letters – resulting from poorly organized and/or incomplete DMFs – putting our clients’ reputations at risk.
Our short, intense session will provide both Type III DMF holders and their clients with valuable insights on how to do it right from the start, avoiding deficiencies and dealing with the most frequent issues. Practical, real life examples will be shown and discussed throughout the program.
Explore the benefits of a proactive approach, and save your organization money and headaches:
- Learn how to write, organize and submit a Type III DMF
- Understand the structure and composition of a robust Type III DMF
- Identify proper content and key pitfalls to avoid
- Get organization tips for easier DMF maintenance
- Receive annual updates and other amendments
- Find out how to write Letters of Authorization (LOAs)
- Deal with deficiency letters – appropriately address FDA concerns
- Assess supplier Type III DMFs
- Understand the role Type III DMFs play in the FDA’s guidance on Post Approval Changes (interchangeability)