The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each principal to design, implement, and maintain a combination system that surpasses compliance requirements. The seminar will focus primarily on the principles embodied in CFR Parts 210-211 and ICH Q7A for pharmaceuticals and Part 820 for medical devices as well as pertinent passages of the International Conference on Harmonization (ICH) and the Global Harmonization Task Force (GHTF) guidances.
The attendees will quickly learn and understand the quality systems principles through the many graphical visual techniques used in the seminar. A quality systems approach will be shown that simplifies and reduces the burden of compliance. You might even want to revamp your quality system after participation in the course.
The presenter will also discuss his many experiences designing and implementing quality systems.
Why Should You Attend: Many quality professionals fear the FDA because they perceive the regulations to be very structured and at the same time open for interpretation. They further perceive the FDA as being the experts interpreting the regulations. It is true that the FDA establishes policy for enforcement of the regulations. It should be remembered the regulations came from industry and furthermore, that the regulations are the minimum requirements. When the pharmaceutical GMP`s were issued, it was frequently stated that the regulations would result in only a mediocre or average quality system. This is because more emphasis would be placed on meeting the demand of the regulation, than studying the objective of why the regulation existed.
The FDA has their role and certainly must be respected. But they do not have the experience of implementing and managing quality systems. They look primarily at what or if systems exist. They do not always understand how the systems operate and interact to control all the inputs that results in acceptable and superior products.
Agenda (Duration (All in EST)):10:00am-11:00am-
Module 1: The role of the quality system & and regulatory loop (0:20)
Module 2: Key to success is management involvement, organizing, and training of all functions. (0:40)
11:00am-12:00pm-Module 3: Management of Documentation and Records (0:15)
Module 4: Design Control (0:15)
Module 5: Facilities and Equipment (0:30)
12:00-1:00pm-Module 6: Material Specifications (0:10)
Module 7: Qualification and Control of Suppliers (0:25)
Module 8: Controlling Incoming Materials
1:00pm-2:00pm Lunch hour (0:60)2:00pm-3:00pm-Module 9: Technical and "Administrative" Process Controls (0:10)
Module 10: Master Record Is Key to Successful Process Control. (0:25)
Module 11: Introduction to Deviations & Quality Failures (0:10)
Module 12: Validation (0:15)
3:00pm-3:30pm: Module 13: Designing & Maintaining Master Labels (0:15)
Module 14: Labeling and Packaging Controls (0:15)
3:30pm-3:45pm Afternoon Break3:45-4:45pm-Module 15: Storage and Distribution (0:05)
Module 16: Returned and Salvaged Products (0:05)
Module 17: Laboratory Controls (0:25)
Module 18: Problem Solving-Nonconforming, Investigations, and CAPA systems (0:25)
4:45-5:00 or more-Questions & Answers
Who will benefit: - Quality, quality control, regulatory, engineering, and manufacturing and IT staff working in the FDA regulated industry in the development and manufacture of medical products.
- Interdepartmental functions associated with scaling up and commercializing a new medical product
- Suppliers and software vendors, servicing the FDA regulated industry, who want to better understand the customer s needs and requirements.
