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Courses

  • 1 Request Info

    Webinar On Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance

    This course provides a background to safety reporting. There is a refresher on the definitions and reporting requirements of AE, SAE, AR and SUSARs, within a clinical trial. We look at the sources of safety information and discuss the evidence that points to the causality of an event. The change in the regulatory environment is reviewed and the role of conditional approval and PASS and PAES studies is also discussed.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/DRUG-SAFETY-PHARMACOVIGILANCE-504550/MARCH-2017-ES-TRAININGREGISTRY
  • 2 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.
  • 3 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?
  • 4 Request Info

    Seminar on 21 CFR Part 11 compliance for software validation and SaaS/Cloud

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
  • 5 Request Info

    2017 HIPAA Changes

    This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2017 and beyond.
  • 6 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.
  • 7 Request Info

    How to Deal With the Disruptive Practitioner

    Disruptive activity by practitioners in the hospital takes many forms. When it happens, it is important that the hospital and/or the medical staff take appropriate steps to see that it does not affect patient care or disrupt operations. Hospital executives, medical staff officers, and peer review committee members and support staff should attend to learn how to deal effectively with the disruptive practitioner. You will also learn how to prepare for the day when it becomes necessary to terminate such a practitioner’s privileges and medical staff membership. You will also gain an understanding of how to develop provisions in the medical staff bylaws to deal with the disruptive practitioner and how to develop a clear and concise policy regarding disruptive behavior. We will discuss the elements of an effective policy and the actions that should be taken to develop progressive discipline and/or sanctions that should be taken before taking action under the corrective action procedures.
  • 8 Request Info

    Avoiding Critical R&D Formulation/Drug Delivery Errors

    We hopefully learn from our mistakes. But, it is far better to learn from other people’s errors and avoid them in the first place. In nearly 40 years of R&D in the pharmaceutical industry, I’ve made--and seen-- some doozies— technical errors, miscommunications, strategic planning oversights, and quite a few “political” blunders. Many, if not all, were preventable. All were costly! For example, over a multi-year period, our manufacturing plant had an occasional release-assay failure, for commercial heparin in intravenous bags. The plant did not consider it a serious problem because re-testing, with a larger sample size, nearly always was successful; the problem was attributed to assay-error and most of those lots were released. Suddenly, every batch failed. It was only then, that the Manufacturing Group got our R&D involved.
  • 9 Request Info

    21 CFR Part 11 compliance for software validation and SaaS/Cloud

    Overview: • This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. • Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
  • 10 Request Info

    Webinar On Foreign Earned Income: Form 2555 Exclusion Reporting and Other Tax Issues for Expat Workers

    This webinar will provide tax advisers and preparers with an in-depth review of complex income tax considerations related to Americans working abroad. Speaker will explore elections and procedures that may have significant income tax consequences for the worker and, in some cases, the sponsoring employer. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/FOREIGN-EARNED-INCOME-EXCLUSION-REPORTING-AND-PLANNING-ISSUES-508431/FEBRUARY-2017-ES-TRAININGREGISTRY
  • 11 Request Info

    Singapore Seminar for Applying ISO14971 and IEC62304

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.
  • 12 Request Info

    Singapore Seminar on Pharmaceutical Water Systems 2017

    This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.
  • 13 Request Info

    Best Practices for Applying ISO14971 and IEC62304 in Zurich

    Overview: This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. Location: Zurich, Switzerland Date: May 18th & 19th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Hilton Zurich Airport Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland Price: Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate) Until April 10, Early Bird Price: $1,695.00 from April 11 to May 16, Regular Price: $1,895.00 Register for 5 attendees Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)* Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900892SEMINAR?channel=mailer&camp=seminar&AdGroup=trainingregistry_May_2017_SEO
  • 14 Request Info

    Webinar On Powers of Attorney: Medical Records Release Concerns

    This live webinar will educate you on how to identify a valid power of attorney to determine whether information should be disclosed. Additional discussions will be held on other issues surrounding access to patient health information such as health care proxies and subpoenas. You need to understand the nuances of patient information requests and the authority you can rely on when turning over patient health information.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/POWER-ATTORNEY-MEDICAL-RECORDS-507407/FEBRUARY-2017-ES-TRAININGREGISTRY
  • 15 Request Info

    Webinar On Trial Master File (TMF): FDA Expectations from Sponsors and Sites

    The recommended and required contents of the trial master file (TMF) continue to be a concern for clinical trial professionals. All companies and investigators conducting clinical trials in the pharmaceutical/biotech industry maintain documentation for each clinical trial. Each company has their own unique TMF structure as defined by their SOPs however many are not clear on the regulatory expectations.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/TRIAL-MASTER-FILE-TMF-505044/FEBRUARY-2017-ES-TRAININGREGISTRY
  • 16 Request Info

    Webinar On HIPAA Compliance in 2017: Changes under Omnibus Rule and Best Practices

    This training will address how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/HIPAA-COMPLIANCE-2017-502062/FEBRUARY-2017-ES-TRAININGREGISTRY
  • 17 Request Info

    Webinar On Challenges with the NOTICE Act and the MOON Form: Is your Hospital/CAH Facility Ready for the Upcoming March 8 Implementation

    CMS has recently posted its updated version of the Medicare Outpatient Observation Notice (MOON), a standard notice that all hospitals and critical access hospitals must provide to Medicare beneficiaries who receive outpatient observation services for more than 24 hours. All hospitals and critical access hospitals (CAHs) are required to provide the MOON beginning no later than March 8, 2017.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/CHALLENGES-NOTICE-ACT-MOON-FORM-502058/FEBRUARY-2017-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar On The Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under one Umbrella

    As the global distributers and manufacturers of Medical devices and pharmaceuticals expand their quality management system (QMS) to cover the pharmaceutical and medical device requirements under one umbrella, the need to understand the quality system requirements that are unique to each industry becomes very crucial.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/BLUE-PRINT-PHARMACEUTICAL-MEDICAL-DEVICE-501995/JANUARY-2017-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar On How to Write HIPAA Policies and Procedures

    The webinar will explain for HIPAA covered entities and business associates the process of drafting, adopting and implementing HIPAA compliance policies. Writing a policy is easier than one may think. It is a three-step process: Researching, drafting, and revising. This webinar will teach you to ask questions, solicit help, collect samples, keep the principles of substance, organization, coherence, style and correctness in mind while you are drafting, send your draft out for review, incorporate comments, implement the policy and repeat as necessary.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/HIPAA-POLICIES-PROCEDURES-501977/DECEMBER-2016-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar On Ensuring Compliance with ICH GCP E6 (R2) Requirements: Meeting the challenges of RBM

    This training will look at the principles of risk management and how they apply in RBM. We will look at the changing regulatory environment with a focus on the changes outlined in ICH GCP E6 (R2) and how these changes may impact your clinical trials.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/COMPLIANCE-ICH-GCP-E6-R2-501987/DECEMBER-2016-ES-TRAININGREGISTRY