Dev Raheja speaker of compliance global

23
Thursday
April, 2015

Speaker: Dev Raheja
Duration: 60 Minutes
Product ID: 700054

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Process Validation with a Product Lifecycle Concept to Meet FDA Requirements

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.

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Dev Raheja speaker of compliance global

27
Friday
March, 2015

Speaker: Dev Raheja
Duration: 90 Minutes
Product ID: 700028

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Failure Mode and Effects Analysis for Joint Commission Requirements

Failure mode and effects analysis (FMEA) is one method hospitals can use to comply with the requirement by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) that they conduct at least one proactive risk assessment of a high-risk process each year.While it is not the only means of satisfying the requirement,Failure Mode Effect Analysis is used to assess the efficacy and efficiency of medical devices.

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Moving from an Operational Manager to a Strategic Leader

Speaker: Chris DeVany

Time: 01:00 PM EDT | 10:00 AM PDT
Location: New York

Logistics Channel Incoterms Standards

Speaker: Dr. Rossano V. Gerald

Time: 01:00 PM EDT | 10:00 AM PDT
Location: New York

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