Jasmin NUHIC- speaker 2011 - Design Controls: What to know when it comes to FDA regulated industry?

Since 1984, the FDA has identified lack of design controls as one of the major causes of device recalls.

The SMDA provided the FDA with the authority to add preproduction design controls to the device GMP regulation.

The design control requirements are not intended to apply to development of concepts and feasibility studies.

Preamble #62
FDA will evaluate the process, the methods, and the procedures that a manufacturer has established to implement the requirements for design controls.

The FDA has amended the IDE regulation, reaffirming that an IDE device is exempted from complying with the GMP’s … with the exception of Sec. 820.30 “Design Controls.”FDA will not inspect design controls during bioresearch monitoring inspections.The concept of an environmental management system evolved in the early nineties and its origin can be traced back to 1972, when the United Nations organised a Conference on the Human Environment in Stockholm and the United Nations Environment Programme (UNEP) was launched (Corbett & Kirsch, 2001). These early initiatives led to the establishment of the World Commission on Environment and Development (WCED) and the adoption of the Montreal Protocol and Basel Convention.
In 1992, the first Earth Summit was held in Rio-de-Janeiro (Jiang & Bansal, 2001), which served to generate a global commitment to the environment (RMIT University). In the same year, BSI Group published the world's first environmental management systems standard, BS 7750.[1] This supplied the template for the development of the ISO 14000 series in 1996, by the International Organization for Standardization, which has representation from committees all over the world (ISO) (Clements 1996, Brorson & Larsson, 1999). As of 2010, ISO 14001 is now used by at least 223 149 organizations in 159 countries and economies.

Why should you Attend

In the global economy and supplier partnership, it is critical that every product development process for product, service or logistics, is well design - that the design inputs are well defined, design outputs are documented and auditable as well as design transfers are successful. There are millions of dollars spent on design transfers that are not effective - and instead of creating a benefit and remove liability, they instead increase the liability and risk. They have been number of FDA finds and warning letters issued against the design control processes to all sizes of medical and pharmaceutical manufactures. This topic is becoming ever increasing as we are being pressured to design faster, transfer faster, make faster yet never compromised quality, compliance, risk, or profit.

Areas Covered in the Session:

- Medical Device, FDA & CFR
- Design Control Introduction
- Design & Development Planning
- Design Input
- Design Output
- Design Review
- Design Verification
- Design Validation
- Design Transfer
- Design Changes
- Design History File

Who will benefit:

- Quality Managers
- EHS managers
- Small business owners
- CAPA investigators
- Project managers
- Product development engineers
- Consultants

Free Handouts: Medical Device, FDA & CFR

Meet You Speaker:

Salim Khan: He holds a master degree in Manufacturing Engineering, an MBA and BS in Mechanical Engineering. He is also ASQ certified Six Sigma Black Belt, Certified Reliability Engineer, Certified Quality Engineer. Salim has successfully implemented several design control and risk management processes for medical device companies. He also has extensive experience in developing efficient product development process. He enjoys statistics and has completed several process validations.