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Courses

  • 281 Request Info

    HIPAA - How Business Associates Can Comply Calmly, Confidently and Completely 2017

    HIPAA Rules are easy to follow, step-by-step, once you know the steps. In this seminar Paul Hales will capture your attention with visual presentations, exercises and discussion that explain HIPAA compliance in plain language. And he will show you how to find the exact steps - when you need them - to comply with every topic in the HIPAA Privacy, Security and Breach Notification Rules Key Takeaways: Clear Understanding of the HIPAA Privacy, Security, Breach Notification Rules What they are - How they work together to affect Business Associates and Covered Entities (Health Care Providers, Health Plans and Health Care Clearinghouses) Origin of the HIPAA Rules - How they are changing - What to expect next How the HIPAA Rules affect and specifically apply to Business Associates Specific HIPAA Compliance Requirements for Business Associates Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901390SEMINAR?trainingregistry-December-2017-SEO
  • 282 Request Info

    Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing 2017

    The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary recommendations Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901366SEMINAR?trainingregistry-December-2017-SEO
  • 283 Request Info

    FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016

    The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA's authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (water pipe) tobacco, pipe tobacco and nicotine gels, among others. The rule went into effect on August 8, 2016. This action is a milestone in consumer protection. Going forward, the FDA Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901294SEMINAR?trainingregistry-December-2017-SEO
  • 284 Request Info

    Drug dissolution testing and establishing plasma drug levels in humans

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901306SEMINAR?trainingregistry-December-2017-SEO
  • 285 Request Info

    FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use 2017

    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 how it intends to manage the health risks with premarket and postmarket controls. What the FDA did not see was the cancer of cybersecurity attacks, the failure of interoperability, Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901106SEMINAR?trainingregistry-December-2017-SEO
  • 286 Request Info

    Data Integrity, 21 CFR 11 & Annex 11 Implementation 2017

    The Problem: 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? I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901052SEMINAR?trainingregistry-December-2017-SEO
  • 287 Request Info

    Webinar On Guidance on Keeping Health Records | Medical Record Retention

    In a complex health services environment with many different health care practitioners, individual practitioners and directors at health care facilities may be confused on how long to retain -- and whether to dispose of -- medical records. Does having digital records require records to be kept indefinitely, or does it simply allow it?Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://onlinecompliancepanel.com/webinar/PATIENTS-MEDICAL-RECORD-506825/OCTOBER-2017-ES-TRAININGREGISTRY
  • 288 Request Info

    Virtual Seminar on Analytical Method Validation Process

    Overview: Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods. Why should you Attend: Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, strength, quality, purity and potency of the drug substances and drug or other products.
  • 289 Request Info

    Webinar On FMEA and Fault Tree Analysis for Preventing Hospital Risks

    Before performing any healthcare act, it is important to understand and identify the possible risks. Once we understand and identify what the risks are, healthcare providers need to decide on their response to that risk and the different scenarios they may be faced with. This has to be done before any harm is done to patients. Two methods of doing this are the Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/FMEA-AND-FAULT-TREE-ANALYSIS-FOR-PREVENTING-HOSPITAL-RISKS-505276/OCTOBER-2017-ES-TRAININGREGISTRY
  • 290 Request Info

    HIPAA Privacy, Security and Breach Notification Compliance 2017

    This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901357SEMINAR?trainingregistry-November-2017-SEO
  • 291 Request Info

    FDA Scrutiny of Promotion and Advertising Practices 2017

    If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901102SEMINAR?trainingregistry-November-2017-SEO
  • 292 Request Info

    A Risk Based Approach to Testing of Computerized GxP Systems 2017

    Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11. "Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits and error handling should be considered" The regulated company is responsible for demonstrating compliance and fitness for use. Effective testing demonstrates compliance with regulatory requirements and ensures patient safety, product quality and data integrity as a result of controlling identified risks. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901360SEMINAR?trainingregistry-November-2017-SEO
  • 293 Request Info

    HIPAA Compliance for Small Healthcare Providers 2017

    Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that you also have the proper policies and procedures in place. If audited or the subject of a compliance review, you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901282SEMINAR?trainingregistry-November-2017-SEO
  • 294 Request Info

    Compliance Boot Camp 2017

    This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901152SEMINAR?trainingregistry-November-2017-SEO
  • 295 Request Info

    GMP and Regulatory Expectations for Early IND Products 2017

    This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901321SEMINAR?trainingregistry-November-2017-SEO
  • 296 Request Info

    Supplier Management for Medical Device Manufacturers 2017

    Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901162SEMINAR?trainingregistry-November-2017-SEO
  • 297 Request Info

    Complaint and Recall Management: A Compliant, Lean Program 2017

    Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901336SEMINAR?trainingregistry-November-2017-SEO
  • 298 Request Info

    21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2017

    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901297SEMINAR?trainingregistry-November-2017-SEO
  • 299 Request Info

    Statistical Methods: A Visual Approach 2017

    An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present methods to allow you to interactively discover relationships graphically. We will provide the foundations for creating better graphical information to accelerate the insight discovery process and enhance the understandability Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901116SEMINAR?trainingregistry-November-2017-SEO
  • 300 Request Info

    Statistics for the Non-Statistician 2017

    If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. Statistics of course, requires constant practice. This seminar will be highly interactive and participative. Participants apply their learning of statistics to real-world example data sets. The program begins by providing a basic overview of the most common statistical tools and terms. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900982SEMINAR?trainingregistry-November-2017-SEO