Duration: 2 DAYS | Course Director: KELLY THOMAS
Is a cybersecurity patch or update a reportable event under the Reports of Corrections and Removals regulation? (21 CFR Part 806) The FDA issued a guidance document recently entitled, “Postmarket Management of Cybersecurity in Medical Devices.” It explains that a patch or update to correct and/or prevent a cybersecurity breach or weakness does not necessarily require a report under Part 806. Whether the District Office recall coordinators still expect a report is not addressed. The ONC established the Information Sharing Analysis Organization (ISAO) that provides a forum for manufacturers to voluntarily participate in what could be seen as a self-help group. Participation in the ISAO gives you a pass on reporting under Part 806. Why? The FDA cannot address the overwhelming volume and aggressive evolution of cybersecurity problems with medical devices. Sadly, the problems involve more than devices themselves, it cascades into bad publicity and patients become alarmed due to the publicity of cybersecurity attacks. The problem is not limited to devices alone, healthcare facilities find their software systems are held ransom until they pay for a restoration, a coercive extortion. Without institutional software, current medical care procedures grind back to a manual program, much like a flashback to SOPs in the 1950s. Patients on life support and life sustaining devices are placed in immediate danger. The National Institute of Standards and Technology (NIST) is trying to make headway in providing guidance on how to manage these kinds of issues that plague devices and health care organizations. Neither you nor the FDA can keep up with preventative measures. Hackers are ahead of the game. The webinar will address how the federal government is creating a forum for manufacturers to share information and their experiences concerning cybersecurity. Maybe reporting a patch or update under Part 806 is an acceptable cost for not participating in the ISAO program. There are issues lurking behind the use of the ISAO forum. Make sure you consider the issues that are included in this webinar. Areas Covered in the Session : FDA Guidance and Strategy Industry wide approach Regulatory relief from required reports Management of Health Information National Institute of Standards and Technology Cybersecurity guidelines Business risks vs. benefits for application interface programs (AIP) Hospital extortion FBI warning to the medical device industry Who Will Benefit: Regulatory Affairs Departments Quality Assurance Departments Software Design Engineers Manufacturing Departments Compliant Departments Hospital Risk Departments Software Program Marketers IT Security Departments Marketing Departments Home Healthcare Services Healthcare Information Protection Departments Capital Venture Firms Medical Device Consultants
The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There are international and federal regulations that describe what aspects should be considered during manufacturing. This webinar will go into detail on those regulations and how they apply to pharmaceutical and biopharmaceutical manufacturing. Areas Covered in the Session : Provide background information on what microbiological aspects to audit. What international regulations should be referenced. ISO classification of rooms and how it should be applied Validation and qualification of bioburden and manufacturing suites. Key sources of microorganisms and why this is important What the source means in terms of root cause Product bioburden and why bioburden is important. Who Should Attend: Quality Departments Manufacturing Departments Engineering Departments Regulatory Departments Microbiologists Contract Manufacturing Organizations
Just as everyone was beginning to get conversant with GDUFA’s confusing three-tier system, the FDA, on July 4, 2018, finalized the GDUFA II guidance! The final guidance simplifies the designation of amendments into two broad categories—Standard or Priority—while classifying them as either Major or Minor. But that has not yet made things easier for many ANDA (Abbreviated New Drug Applications) applicants. There’s still a lot of ambiguity around amendments to ANDAs and PASs (Prior Approval Supplements) – and not having clarity could cost your organization time, money, and other resources. This webinar will walk you through the amendment format and submission process. You will learn how the GDUFA II review goals apply to amendments to ANDAs and PASs; how the amendment submissions may affect the review goal dates; how ANDA or PAS deficiencies may cause the FDA to request a major amendment, as well as how to request the FDA to reconsider classifying a major amendment. This webinar will bring absolute clarity on the FDA review goals for amendments under GDUFA II. After attending this webinar, you will achieve a greater working understanding of GDUFA II and its most recent final guidance. Moreover, you’ll also get to know how the FDA will process amendments submitted before GDUFA II. Plus, you’ll be confident in your ability to bring generic drugs to market quickly and in compliance with the GDUFA II requirements. Areas Covered in the Session : Purpose and scope of GDUFA II The FDA’s process for classifying major, minor, and unsolicited amendments to ANDAs or PASs The amendment format and submission process The FDA review goals for amendments under GDUFA II How the FDA will process amendments submitted before GDUFA II How ANDA or PAS deficiencies cause the FDA to request a major amendment or classify deficiency responses as a major amendment How to request the FDA to reconsider classifying a major amendment How high quality standards are maintained through inspections and risk-based approaches The process of and reasons for requiring the identification of the facilities involved in the manufacture of generic drugs and the associated Active Pharmaceutical Ingredients (APIs) How amendment submissions may affect review goal dates Who Should Attend: Compliance and regulatory affairs professionals Project managers QA & QC managers R&D staff Generic drug manufacturers API manufacturers ANDA sponsors Consultants Directors, associate directors and associates Generic drug industry professionals