Design Controls: What to know when it comes to FDA regulated industry?

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 designed - 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. There have been number of FDA findings and warning letters issued against the design control processes to all sizes of medical and pharmaceutical manufactures.

This 2-hr session will review the FDA design control requirements under GMP regulations and show how, as a medical device manufacturer, you can design faster, transfer faster, make faster yet never compromised quality and be in full compliance with FDA requirements. By attending this training, you will be in a position to ensure that your process, the methods, and the procedures that you have established to implement the requirements for design controls are in perfect order.

Areas Covered in the Seminar:

• 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:

• Product development engineers
• Quality Engineers
• Quality Managers
• Small business owners
• CAPA investigators
• Project managers
• Consultants
• AdvaMed companies

Instructor Profiles:

Jasmin NUHIC - Professional with proven record of leading teams that deliver projects in full scope, below a budget and ahead of schedule through process optimization, business growth and talent development. Over 12 years of experience in FDA regulated industry with vast experience in operations, quality management systems, manufacturing, concurrent engineering, program management and information systems. Positive and verifiable track record in continuous improvement and cost saving initiatives through use of lean sigma and six sigma methodologies.

Salim Khan - 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.

Topic Background:

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.

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