1000+ Sessions conducted on USFDA,EMA and APAC

Tuesday, 30th April, 2024 01:00 PM EST 10:00 AM PST

To attend this webinar kindly call 1-646-216-8860 or email at marketing@biopractice.com

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. However, there are ways to validate equipment already in use!

This webinar will discuss Equipment Calibration Requirements, Preventive Maintenance Requirements, when to use Calibration when to use Maintenance, what is Remedial Action for Out-of-Calibration Equipment, how to use of Calibration Standards to Save Cost.

Areas Covered in the Webinar:

• Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification..
• Equipment Preventive Maintenance Requirements.
• Calibration vs. Maintenance: When to use Which One?
• Remedial Action for Out-of-Calibration Equipment.
• Use of Calibration Standards to Save Cost.
• Equipment Calibration Requirements: Scheduling, Use of External Services, and Documentation.

Jeff Kasoff, RAC, CQM/OE, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS in 1996, his Manager of Quality and Organizational Excellence certification from ASQ in 2013, and his Lean Black Belt from IIE in 2014.

Friday, 3rd May, 2024 01:00 PM EST 11:00 AM PST

FDA regulates all labeling for medical devices. This webcast outlines the general labeling requirements for all medical devices – including over-the-counter devices, IVD devices, investigational devices, and electronic/radiation-emitting devices. The webinar explains concepts such as “label” vs. “labeling”, “adequate directions for use”, “claims”, “intended use”, “indications for use”, and “off-label use”. It includes short discussions of electronic labeling UDI (Unique Device Identifier) requirements, advertising/promotion of medical devices using product claims and promotional claims, and off-label use of devices.

Areas Covered in the Webinar:

• FDA requirements
• UDI, Standardized Date Format, GUDID
• Claims – product claims and promotional claims
• Intended Use and Indications for Use
• Off-label use – What is it? When is it OK to distribute information on off-label use?

Sheila Ramerman, RAC, is the founder and Principal Consultant at SJR Associates, a medical device regulatory affairs/quality systems consulting firm with particular emphasis on near-patient testing technologies and in assisting start-up stage companies implement their regulatory, quality, and clinical studies functions. Prior to founding SJR Associates, Ms. Ramerman was responsible for regulatory affairs, quality systems, and/or clinical studies at several medical device companies in the San Francisco Bay Area. She has hands-on experience with a wide variety of medical devices, and has worked with a range of medical device companies, from start-ups to multi-national corporations. She has been Regulatory Affairs Certified (RAC) since 1998.