Medical Devices
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Statistical Process Control (SPC)
Description: All companies want to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The... -
Normality Tests and Normality Transformations
Description: The calculations used in many statistical tests and methods require that the inputted data be “normally distributed”. Such calculations include those for t-Tests, ANOVA tables, F-tests, Tolerance limits, and Process Capability Indices. Unless the raw data used in... -
Process Capability Analysis using Confidence/Reliability Calculations
Description: All manufacturing and development companies perform testing and/or inspections that involve concluding whether or not a product or lot is acceptable vs. design or QC specifications. Such test/inspections may occur during design verification/validation or during incoming or final... -
Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements
Description: This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now, the... -
Failure Investigation, Root Cause Analysis – Tools and Techniques
Description: Failure Investigations (FI) and Root Cause Analysis (RCA) are vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program, often required in product or equipment validations. Rigorous FI and RCA show a company’s Quality Management... -
Prepare for Your cGMP Inspection
Description: This webinar will focus on the U.S. FDA’s FY 2013 cGMP audit issues, recent guidance documents and stated 2014 initiatives. Issues discussed should be a key consideration of a company’s Internal Audit Program, and annual Quality Management Review.... -
The 510(k) Program: Substantial Equivalence In Premarket Notifications
Description: This guidance was released on July 28, 2014. FDA developed this document to provide guidance about current review practices for premarket notifications (510(k)) submissions. FDA’s intent is to identify, explain and clarify each of the critical decision points... -
The Quality System Regulation: FDA’s Medical Device GMP
Description: This webinar is a must attend for those personnel that require an understanding of the regulation governing FDA’s Medical Device manufacturing operations. FDA’s regulates the manufacture of Medical Devices under the Quality System Regulation (QSR) 21 CFR Part... -
Medical OEM Design Control Audit: Expectations
Description: This 60 minute webinar on a Design Control Audit by the FDA and other bodies will provide an understanding of what a medical OEM should anticipate during an audit during a design control audit. All medical device companies... -
Transferring OEM Medical Device Production to a Contract Manufacturer – Decision Making Process with Procedures and Full Validation
Description: This webinar will provide methodology, processes and procedures to all medical OEM’s that have to make critical decisions concerning transferring equipment, molds, dies, systems and processes to contract manufacturers. It will follow a recent successful case study in... -
Transferring OEM Medical Device Production to a Contract Manufacturer – Decision Making Process with Procedures and Full Validation
This webinar will provide methodology, processes and procedures to all medical OEM’s that have to make critical decisions concerning transferring equipment, molds, dies, systems and processes to contract manufacturers. It will follow a recent successful case study in the... -
Medical OEM Design Control Audit: Anticipation and Expectations
Description: This 60 minute webinar on a Design Control Audit by the FDA and other bodies will provide an understanding of what a medical OEM should anticipate during an audit during a design control audit. All medical device companies... -
How to Develop a Master Validation Plan
Description: Every medical device company (OEM) must meet certain standards for validation of its transfer plans, facilities, clean rooms and processes. These standards apply for OEM’s and suppliers to OEM’s. Many medical companies have never had a Master Validation... -
Medical Device Cleanliness: When and How to adjust LIMIT VALUES for Residual Analysis
Description: This webinar will provide valuable guidance to medical device manufacturers on how to establish and justify limit values for cleanliness. There are several techniques that may be used to set these limits, including comparison involving statistics and historical... -
Acceptance Activities in FDA QSR
Description: For device company Warning Letters in 2012, Acceptance Activities, 820.80, was the fourth most frequently cited QSR section. The trend continues in 2013. Not only are acceptance activities important for themselves, they link to many other QSR sections.... -
Cyber Security Planning for Medical Devices
Description: How you manage cyber security issues for medical device software raises serious concerns at FDA. Software is subject to a number of FDA requirements, such as the Quality System Regulation design control requirements. In adequate cyber security measures...
