Data integrity is an ever-increasing concern in life sciences evidenced by the recent activities of the FDA placing its watchful eye on the evolving medical device industry, for the purpose of ensuring safety, and enhancing quality among all manufacturers. Coming under recent scrutiny in the area is data integrity and its far-reaching impact on manufacturing safety and product quality.
Users or their manufacturers must satisfy established criteria with computer data that is created, shared, modified, or accessed by medical devices. Data and devices that come up short of these specifications may also fail to realize acceptable integrity standards when confronted with exacting regulatory oversight.
“Navigating the maze of rigors, safeguards and protocols needed to maintain integrity and quality requires a comprehensive approach that includes robust processes and a dedicated adherence to their continuous application,” explains Scott Deckebach, Director in the Compliance practice at Lachman Consultant Services, Inc. specializing in data integrity (Lachman Consultants).
To help manufacturers better understand, establish, and maintain data integrity, Lachman Consultants will present, “DATA INTEGRITY: Manufacturing & Quality,” a FREE webinar hosted by Mr. Deckebach. This latest Lachman Learning Experience offering takes place on Wednesday, December 1st at two different times, 12PM-2PM EST and 11:30AM-1:30PM IST. The event will include an oversight and explore some of today’s most critical data integrity concerns, including processes and quality systems.
Mr. Deckebach is a life sciences and medical device regulatory compliance manufacturing, and technology expert, with more than 25 years of experience in the industry. He has been affiliated with Lachman since 2015 when he joined the Compliance team as a Senior Associate. His client services have also included IT strategies and solutions, and computer systems validation.
Register here for 12:00PM – 2:00PM EST
Register here for 11:30AM – 1:30PM IST