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Courses

  • 81 Request Info

    Effective Batch Record Review

    Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
  • 82 Request Info

    Effective Environmental Monitoring Program: Best Practices in Bio/Pharmaceutical Production

    Recent consent decrees have highlighted the importance that the FDA has put on environmental monitoring as a way of verifying control of the operational environment, along with the expectations when sampling methods yield positive results. Whether environmental monitoring is used simply to verify a state of cleanliness within a packaging area or during the production of sterile products, the assurance for sterility or area cleanliness is dependent not only on cleaning and sterilization methods used, but also with the control of the environment in which they are produced.
  • 83 Request Info

    Effective FDA and ISO Management Reviews

    Overview: In this presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Management review should be a key part of keeping your quality management system efficient and effective. Why should you Attend: Are your management reviews effective or do you have trouble getting senior management engaged? Perhaps you are not using an effective approach that fits your company or your management.
  • 84 Request Info

    Electronic Health Records Software License Agreements 2016

    Overview: For physician practices just setting foot into the EHR arena, and for those practices transitioning to a new EHR software package, the fundamental document controlling their experience will be the EHR license agreement. The license agreement will -- or should -- determine issues such as how whether and how often the vendor may make online portions of the software unavailable for maintenance or other issues; how many people may use the software and on how many machines the software may be installed Price : $139.00 Contact Info: MentorHealth Phone No: 1-800-385-1607 FaX: 302-288-6884 support@mentorhealth.com Event Link: http://bit.ly/Health-Records-Software-License-Agreements http://www.mentorhealth.com/ LinkedIn Follow us – https://www.linkedin.com/company/mentorhealth Twitter Follow us – https://twitter.com/MentorHealth1 Facebook Like us– https://www.facebook.com/MentorHealth1
  • 85 Request Info

    Ensuring Data Integrity and Safety in Clinical Research

    Overview: Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11. Why should you Attend: The increasing use of computers and increasing complexity, all persons who have any data input requirements to know the set-up and function of the systems they are using. Forewarned is forearmed. Areas Covered in the Session: The CFR definitions of Electronic Record, Electronic Signature, Closed System, Open System, Data Trails, and assure that your data is secure and valid? What needs to happen to make data trails secure and real What questions should you internal QA department ask to be sure your system is functioning correctly? What controls need to be in operation for an open system? What are the controls needed for a valid electronic signature?
  • 86 Request Info

    Essentials of Validation - IQ, OQ, PQ

    Overview Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management. We'll cover the steps of Installation Qualification (IQ),Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
  • 87 Request Info

    Ethical Challenges in a Digital World and Ethical Decision-making Strategies

    Overview: Today's behavioral health practitioners face a wide range of unprecedented ethical challenges related to their use of digital and other technology. Is it ethical for practitioners (mental health counselors,social workers, psychologists, psychiatrists, marriage and family therapists, and substance use counselors) to use technology to provide services remotely to clients they never meet in person?
  • 88 Request Info

    EU Clinical Trial regulation - 2017

    Overview: Transition between Directive 2001/20/EC and Regulation EU No 536/2014 Until the Clinical Trials Regulation EU No will become applicable, all clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive 2001/20/EC. This Directive will be repealed on the day of entry into application of the Clinical Trial Regulation.
  • 89 Request Info

    EU Clinical Trial Regulation Implementation | Regulatory 2018

    This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, the seminar will cover the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing]. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901354SEMINAR?trainingregistry-February-2018-SEO
  • 90 Request Info

    Excel Spreadsheet Validation 2018: Tools and Techniques to Meet FDA Requirements

    Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.
  • 91 Request Info

    Excel Spreadsheet Validation for FDA 21 CFR Part 11 (2019)

    Overview: These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment. Why should you Attend: Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance.
  • 92 Request Info

    Expediting New Products and New Product Indications

    This webinar will explain how the 21st Century Cures Act will impact the current pharmaceutical and medical device industries, particularly their processes for new product and new product indication requests, It also provides new authority to help FDA improve our ability to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs.
  • 93 Request Info

    Explores New SAMHSA Confidentiality Law for Substance Use Disorder Records(42 CFR Part 2)

    This webinar will guide healthcare professionals, health IT vendors, and insurance companies to maintain information security and patient confidentiality
  • 94 Request Info

    FDA - Legal Writing Skills that Result in Effective Regulatory Submissions

    Overview: Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.
  • 95 Request Info

    FDA Data Integrity for Computerized Systems: Combat the Misconceptions of 21 CFR 11 & Annex 11

    We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News Overview and Key Requirements of Part 11 & Annex 11 How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
  • 96 Request Info

    FDA General Principles of Software Validation | Cyber Security 2018

    Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice. The FDA looks at software in one of three ways: Standalone, such as for a mobile app; device-based software used to control a device's performance, or simply electronic records. FDA's risk classification will gradually clarify keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901393SEMINAR?trainingregistry-January-2018-SEO
  • 97 Request Info

    FDA Guidelines for Pharmaceutical Industry | FDA Regulatory 2018

    The FDA is increasing its enforcement actions both for domestic and foreign inspections. Enforcement statistics have not been summarized yet because 2017 has not ended yet. We are certainly seeing more Warning Letters and Import Alerts based on Data Integrity (21 CFR Part 11: Electronic Records; Electronic Signatures. In the past FDA used to issue several Warning Letters to the same firms upon consecutive inspections. Today, after receiving one Warning Letter the next regulatory action is elevated to Import Alert, Consent Decree, and Injunctions for domestic manufacturers. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901471SEMINAR?trainingregistry-March-2018-SEO
  • 98 Request Info

    FDA Inspection and Respond to 483 & How to Prepare them - 2017

    Overview: In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection. Why should you Attend: FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.
  • 99 Request Info

    FDA Inspections: From SOP to 483 in (2019)

    Overview: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? Why should you Attend: This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
  • 100 Request Info

    FDA Process Analytical Method Validation

    Overview: An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Why should you Attend: Observations that test methods are inadequate or the firm does not have appropriate data that demonstrates the method performs as intended rank high on the list of observations in the laboratory.