Casper E Uldriks
Washington, District of Columbia - Counsel
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
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Recorded Webinar
Stunning Changes in FDA's Software Regulation
Congress removed some software products out of FDA's jurisdiction. On balance, the benefit did not outweigh the cost of the regulatory burden. That is a stunning "least burdensome approach." FDA is planning to give additional regulatory relief to its regulation of software. Now the question is whether or not you are in a "relief zone." Those boundaries are grey. We are looking at no regulation of some software, easier regulation for some software premarket (510(k)) submissions and an accelerated assessment of products deemed part of a "Digital Health" initiative, which has a startling change for premarket access. Firms can clear their own Software 510(k).
Recorded Session Get life time access for one participant with download option!

6-Hour Virtual Seminar on FDA's Moving Target and Hammer for Social Media
FDA's regulation of Social media operates with a moving target. What is OK or not OK remains vague, perhaps purposely so. All social media platforms provide common ways to cross FDA's legal boundaries, whether you do it knowingly or unknowingly. How you salvage your regulatory posture needs a clear corporate policy, procedures and effective implementation. As information increases with technology, FDA will need to analyze what works and what does not from a practical point of view. Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it. FDA has a weak legal history on this topic. Federal courts keep pushing back the Constitutionality of FDA's enforcement actions. The problem is that no one can figure out a clear future for FDA and for themselves. Unfortunately the cost to your business and the confusion left in your customers' mind becomes an unwelcomed nightmare.
Recorded Session Get life time access for one participant with download option!

Cybersecurity Exploitation Recovery
Cybersecurity technology and exploitations evolve rapidly. A static cybersecurity program leaves a software program more vulnerable with each passing day as hackers develop new malware adaptations. The FDA requires that a software developer, whether for a software based device or for standalone software, address cybersecurity before the device may be marketed. But the cybersecurity problems manifest themselves after premarket authorization. FDA provides little guidance on how to manage a cybersecurity recovery program once you are one the market and have been hit. What should your cybersecurity recovery program include? You are left with an answer of, "You figure it out."
Recorded Session Get life time access for one participant with download option!

Manage Your FDA Inspection Before It Happens
The FDA conducts various types of inspections depending on what the firm is doing. Inspections follow fairly predictable patterns. You can identify what factors are relevant for your inspections and how the FDA will work with them. The goal of the virtual seminar is to help you figure out what is relevant for how FDA looks at you. Establishing a well-reasoned inspectional strategy on the basis of relevant FDA factors, and how an inspection unfolds, you avoid or mitigate unnecessary policies and procedures that are premised on a defensive stance or an ad hoc management style, which is usually so anxiety laden that the firm becomes its own worst enemy.
Recorded Session Get life time access for one participant with download option!

FDA's Off-label Promotion in Social Media
The webinar provides insight on how to manage marketing strategies that use social media. A firm's use of social faces FDA restrictions and obligations on how you use social media, what you can say and what you must do to correct misinformation published by third parties that places you at risk with FDA.
Recorded Session Get life time access for one participant with download option!

Managing the FDA form "483": Inspection Observations
FDA inspections look for noncompliance with applicable manufacturing regulations. During the inspection the FDA investigator makes a "list of observations" that gives examples of violations. The list is known as the "483." Some observations are very serious and can easily lead to receiving a Warning Letter, which threatens legal action. Your response to a 483 plays a critical role in how the agency will evaluate the inspection. A poorly written response or not responding at all will certainly lead to a Warning Letter and follow up action by FDA.
Recorded Session Get life time access for one participant with download option!

Stunning Changes in FDA's Software Regulation
Congress removed some software products out of FDA's jurisdiction. On balance, the benefit did not outweigh the cost of the regulatory burden. That is a stunning "least burdensome approach." FDA is planning to give additional regulatory relief to its regulation of software. Now the question is whether or not you are in a "relief zone." Those boundaries are grey. We are looking at no regulation of some software, easier regulation for some software premarket (510(k)) submissions and an accelerated assessment of products deemed part of a "Digital Health" initiative, which has a startling change for premarket access. Firms can clear their own Software 510(k).
Recorded Session Get life time access for one participant with download option!

Cybersecurity Exploitation Recovery
Cybersecurity technology and exploitations evolve rapidly. A static cybersecurity program leaves a software program more vulnerable with each passing day as hackers develop new malware adaptations. The FDA requires that a software developer, whether for a software based device or for standalone software, addressed cybersecurity before the device may be marketed. But the cybersecurity problems manifest themselves after premarket authorization. FDA provides little guidance on how to manage a cybersecurity recovery program once you are on the market and have been hit. What should your cybersecurity recovery program include? You are left with an answer of, "You figure it out."
Recorded Session Get life time access for one participant with download option!

FDA's Off-label Promotion in Social Media
FDA regulates firms’ use of social media to prohibit product information that is deemed false and misleading. Firms bear the responsibility of checking and prohibiting the use of social media that offends FDA’s key limitations of how social media can be used. What can be stated by an individual citizen becomes restrict commercial speech when such statements or related information is attributed to a manufacturer. FDA’s treatment social media as labeling opens up a broad opportunity for FDA to claim your product is illegal. Staying within the vague boundaries of FDA’s social media restrictions can be confusing, surprising and expensive if you have not carefully charted your course on the use of social media.
Recorded Session Get life time access for one participant with download option!

FDA's Off-label Promotion in Social Media
FDA regulates firms' use of social media to prohibit product information that is deemed false and misleading. Firms bear the responsibility of checking and prohibiting the use of social media that offends FDA's key limitations of how social media can be used. What can be stated by an individual citizen becomes restrict commercial speech when such statements or related information is attributed to a manufacturer. FDA's treatment of social media as labeling opens up a broad opportunity for FDA to claim your product is illegal. Staying within the vague boundaries of FDA's social media restrictions can be confusing, surprising and expensive if you have not carefully charted your course on the use of social media.
Recorded Session Get life time access for one participant with download option!

Training Requirements under FDA's Quality System Regulation
Training requirements can make or break a firm's compliance program. A weak training program becomes a weak link in a firm's ability to makea product that conforms to FDA requirements.
Recorded Session Get life time access for one participant with download option!

Managing Foreign Inspections - Before, During and After
The importation of products regulated by FDA has grown steadily and will continue to grow. Manufacturing capacities, international economic growth and new markets drive global commerce and likewise the expansion of imports and exports. Over the past several years, however, problems with foreign manufacturers has become more evident and has prompted Congress and FDA to implement tougher import requirements.
Recorded Session Get life time access for one participant with download option!

Changes in FDA's Device Corrections and Removals Reporting
FDA has proposed a dramatic change to what should be reported under the Corrections and Removals regulation for devices. The change significantly broadens the scope of what is reportable to FDA.
Recorded Session Get life time access for one participant with download option!

FDA Warning Letter Management
A Warning Letter gives you legal notice of possible legal action against you by the FDA. A Warning Letter from the FDA requires a prompt, thorough and realistic response to mitigate further damage to your business. If you do not respond effectively, you face a long and costly task of rehabilitating your FDA regulatory profile with the agency, your customers and your investors. You need to understand how to manage the FDA's Warning Letter to control the possible skyrocketing cost of noncompliance. The FDA warning letter can quickly start to manage you unless you already have in place a plan to manage the Warning Letter. "A stitch in time saves nine."
Recorded Session Get life time access for one participant with download option!

Practical Guide to FDA Inspections
FDA's standard inspectional operations are discussed in the webinar so you can establish or revised your FDA inspection protocol before an inspection occurs. Most FDA inspections follow a standard procedure.
Recorded Session Get life time access for one participant with download option!

FDA Import and Export Requirements
Critical issues will be discussed so you can develop and maintain an effective and efficient import / export business. The topics cover legal requirements and practical business operations. Given the FDA's increased scrutiny of international trade, understanding the following topics is essential.
Recorded Session Get life time access for one participant with download option!

The Infamous Form FDA 483: How you respond can make or break you
The infamous Form FDA 483 (483) presents a list of observations noted by an FDA investigator, a consumer safety officer (CSO,) during the inspection of an establishment regulated by the FDA. The observations point out specific factual situations that in the investigator's view demonstrate an apparent violation of the applicable FDA regulations.
Recorded Session Get life time access for one participant with download option!

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