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

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

This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use. On a regular basis, there are assays that get developed that have a clear utility in the clinic. However, what may be practical within a research context may not be practical within a clinical context. In addition, these assays have to be able to handle clinically relevant samples, which often differ from the samples used in research studies. Unless an assay can give clinically actionable results in a clinical laboratory, whatever utility the assay may have will be useless to clinical practitioners, who have different demands than research laboratories. Why You Should Attend: In this 60-minute training, you will be able to learn what needs to be done to an assay to make sure it is ready for the clinic and how to validate such changes. In addition, you will learn how to select a clinically relevant population for a given assay, validate the assay within such a population and how to select Gold Standards for comparison. Finally, you will be able to develop clinical quality monitoring standards to make sure the assay remains relevant in a clinical context. Areas Covered in the Session : What are the key differences between a research assay and a clinical assay How to make sure an assay can regularly be performed by a medical technologist and how to validate those changes How do you find clinical relevant samples to test your assay against How to find a Gold Standard Assay and develop a validation plan against it How to validate an assay for clinical use How to develop a clinical quality plan to make sure the assay remains valid Who Should Attend: Senior Management Quality Assurance Research and Development Medical Technologists Scientists Regulatory Affairs Validation Specialists All Personnel who perform, supervise, manage, audit or oversee the validation of assays in a laboratory

Most regulatory agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, in order to demonstrate compliance, there must be written procedures for a batch record review process. The production and manufacture of pharmaceuticals, biologics, medical devices, etc., involve critical processing parameters. In order to properly document these processing parameters, a strong batch record review system is essential. This webinar will analyze each of these necessary elements of the batch record review process. Upon completion of this session, you will learn the fundamentals for reviewing batch records in a pharmaceutical environment. You will hear about the proper training that must be demonstrated to be considered a suitable reviewer of these critical documents and you will learn how to react to discrepancies found in these records. Areas Covered in the Session : Recognize regulatory requirements for batch records and batch record review Understand the essential and necessary qualifications and training of batch record reviewers Establish a working relationship between production and quality reviewers What to do when a batch fails to meet specifications (discrepancies and deviations) Parameters of efficient review of batch records – good documentation practices, compliance to essential quality attributes and critical processing parameters Skills and responsibilities of an effective batch record reviewer Tools to achieve an effective batch record review Ensuring Production and Quality reviewers coincide with their reviews Creating an extensive training plan for batch record reviewers and when they can be considered “qualified” to review a record

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This webinar will help you understand in detail the new requirements for trial master files. You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file. FDB3142 Areas Covered in the Session : Trial Master File (TMF) background and rationale Learn what content is required for a TMF for a clinical trial The essential documents to include in a TMF Understand how the essential documents demonstrate the conduct of the regulated activities of the investigator and sponsor Organizing and maintaining a TMF How to provide quality assurance for the data included Standard Operating Procedure required to support TMF Developing a consistent system for locating TMF documents Regulatory Inspection of TMF records and Preparation Industry Standards and Best Practices Interactive Q&A Session Who Should Attend: Lead CRAs CRA Managers Project and/or Study Managers Project and/or Clinical Trial Assistants Clinical Operations Administrators Quality Assurance Personnel Compliance Teams Validation Teams Sponsor and CRO personnel involved in set up, maintenance, and auditing of the Trial Master File for sponsors Consultants Teams involved with CSV Auditors engaged in the internal inspection of clinical trial documentation and practices

Any successful records management plan will start with a benchmark assessment of your current state followed by a data integrity audit. This training program will teach attendees best practices on how to perform audits for data integrity within their organization. Attendees will also learn how to centralize management and eliminate silos. Where are your records, what are the formats, how are they being tagged and classified, what kinds of policies are you applying to management and how well and consistently are you enforcing those policies? This webinar will help attendees learn how to apply consistent Meta tags and policies to all documents and records. It will also teach how to reduce compliance and e-discovery risks. This webinar is designed for people tasked with performing audits for their organizations for data integrity. It is also for those tasked with records management. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment that produces and stores data, processes and documentation. Areas Covered in the Session : Establishing a Baseline Applying consistent meta tags to all documents Applying consistent policies to all records Achieving a best practice level of compliance Inspecting Live Computer Systems for Data Integrity Controls Pattern Recognition Methods Flags for Parallel Record-Keeping Evaluating Data Governance Programs Data Process Maps and Data Life Cycle Assessments Centralizing management and eliminating silos Evaluation of Current Enforcement Trends, including FDA & EU citations Reduce compliance and e-discovery risks Building a better business case Who Should Attend: Senior Quality Managers Quality Professionals Regulatory Professionals Compliance Professionals Production Supervisors Validation Engineers Manufacturing Engineers Production Engineers Design Engineers Process Owners Quality Engineers Quality Auditors Document Control Specialists