- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
Process validation training activities with a product lifecycle management concept and the FDA risk management framework is critical for the medical device industry, because most of the device failures happen from inadequate processes and poor process control systems. Manufacturers of medical devices must meet the requirements of the Quality System regulation for medical devices (21 CFR part 820). The Quality System regulation at 21 CFR 820.5 states that “each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device manufactured
Proper quality control programs help to control or eliminate manufacturing defects. FDA also believes that incoming material and in-process control validations will assure high quality.
why should you attend
Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Too many processes and too many validations are likely to result in too much time and money wasted in addition to FDA warnings. This webinar teaches you how to minimize process controls and process validations.Click to View the Pricing Plan
- FDA quality systems requirements
- Requirements for design and development planning
- Requirements for process inputs
- Requirements for process outputs
- Requirements for process design review
- Requirements for process verification
- Requirements for process validation
- Packaging and labelling process controls
- Requirements for process changes
- Maintenance and inspection of equipment
- Control, use, and removal of manufacturing materials
- Device master record
- Learn to minimize the need for process validation
- Understand the principles of designing a robust process
- Learn to look for advanced warnings of process going out of control
- Learn how to prevent process defects for permanently
WHO WILL BENEFIT
- Senior management
- All manufacturing/production managers
- Manufacturing and production engineers
- Manufacturing supervisors
- Quality assurance staff
- Regulatory affairs staff
- Production operators
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare, medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, and Preventing Medical Device Recalls. He shows clients how to come up with elegant solutions using creativity and innovation. He helped a major Midwest company from going out of business to becoming a world leader by eliminating safety mishaps. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance and Manager of Manufacturing, and at Booz-Allen & Hamilton as Risk Management consultant for nuclear and mass transportation industry.
Currently he is an Adjunct Professor at the Florida Tech for its degree in Healthcare Management, and serves on the Patients and Families Advisory Council at Johns Hopkins Hospital. He is Associate Editor for Healthcare Safety for the Journal of System Safety, and is a member of the American College of Healthcare Executives.View all trainings by this speaker
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Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.