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Courses

  • 301 Request Info

    HIPAA Audits – an Insider’s Perspective

    Overview I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I’ve been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received This HIPAA training will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. For more detail please click on this below link: http://bit.ly/2tkL7wD Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510
  • 302 Request Info

    Combination Products 2017

    This seminar provides Professionals working in this area with A thorough understanding of the complexities involved All the relevant regulations and guidelines Real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901066SEMINAR?trainingregistry-September-2017-SEO
  • 303 Request Info

    Leadership and Team Development for Managerial Success 2017

    Inspire and influence your team members to achieve your goals as a team! Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation.. apply a consistent theory in leading your team.. and teach critical leadership skills to members of your team, so each and every one of them can lead the team in your absence. Why should you attend: Would you like to learn more about the differences between leading and managing? What about understanding how to more clearly visualize your goals and communicate them to your team? How about being able to better target your team's efforts? Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901082SEMINAR?trainingregistry-September-2017-SEO
  • 304 Request Info

    Design of Experiments (DOE) for Process Development and Validation 2017

    Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product. The use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes. Screening designs, such as 2k factorial and D-optimal designs, are used to determine critical process parameters. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901126SEMINAR?trainingregistry-September-2017-SEO
  • 305 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. This starts with the fundamentals of a HIPAA compliance program. If your small healthcare practice needs to understand how to put a HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive Two-day training course. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901024SEMINAR?trainingregistry-September-2017-SEO
  • 306 Request Info

    Writing and implementing effective SOP 2017

    An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901140SEMINAR?trainingregistry-September-2017-SEO
  • 307 Request Info

    Validation of Computer Systems for Quality and Software Embedded Medical Devices 2017

    Understand Verification and Validation, differences and how they work together Develop a "Working Definition" of V&V, Qualification, and related terms Discuss recent regulatory expectations Software Verification & Validation requirements of the FDA and ISO. The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies Device and Manufacturing software requirements for V & V How to determine & demonstrate an appropriate V & V strategy Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900974SEMINAR?trainingregistry-September-2017-SEO
  • 308 Request Info

    How to properly investigate OOS/OOT Results

    Overview The speaker will provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations. This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed. For more detail please click on this below link: http://bit.ly/2ru2Sae Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510
  • 309 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.
  • 310 Request Info

    Validation Program to a Building from Top to Bottom - 2017

    Overview: Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program. Why you should attend: How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program.
  • 311 Request Info

    Best Validation Practices for Laboratory Computer Systems Regulated by FDA

    Overview We will discuss the importance of applying industry best practices when validating laboratory systems that are regulated by FDA. Any “GxP” system (i.e., the system "touches" product during the laboratory testing or process) must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. This FDA Compliance course will describe the best practices for conducting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done. In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators. For more detail please click on this below link: http://bit.ly/2r9k1XA Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515
  • 312 Request Info

    Webinar On IQ, OQ, PQ in the Verification and Validation Process

    This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.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/IQ-OQ-PQ-VERIFICATION-VALIDATION-PROCESS-503654/JUNE-2017-ES-TRAININGREGISTRY
  • 313 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.
  • 314 Request Info

    Validating Radiation Sterilization for Medical Products

    Overview: Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
  • 315 Request Info

    Applying ICH Q3A and Q3B for Control of Impurities

    Overview: This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants (including DNA reactive/potential genotoxic impurities) in drug substances and drug products. There will be ample opportunity to discuss questions and challenges from the participants. Why should you Attend: Upon completion of this course the learner should be able to: Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals Understand what specifications will conform to regulatory expectations Develop an process for reporting impurities and addressing OOS situations
  • 316 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.
  • 317 Request Info

    Webinar On Compliance with EU Regulation for Clinical Trials

    This webinar will help ensure attendees are familiar with new regulations for running clinical trials in Europe. It will help them prepare to implement the new requirements efficiently while elaborating how clinical trials will be authorized in the future. The instructor will also detail the authority proffered to EU regulators to perform inspections of all clinical trials registered in the EU, whether they are conducted within the EU or internationally in other emerging markets.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-EU-REGULATION-CLINICAL-TRIALS-506624/APRIL-2017-ES-TRAININGREGISTRY
  • 318 Request Info

    Webinar On Medical Device Recalls: a Preventive Strategy

    The secret to preventing medical device recalls is to implement and follow basic practices for specifications and design control, design for process reliability, production validation and design validation using accelerated life tests. This webinar is about controlling safety risk from specification writing to device retirement - control throughout the product's life cycle.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/MEDICAL-DEVICE-RECALLS-509325/APRIL-2017-ES-TRAININGREGISTRY
  • 319 Request Info

    Root Cause Analysis to Meet FDA Expectations - 2017

    Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. Why should you Attend: A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that such effective and repeatable failure investigation and root cause analysis is still not the industry norm.
  • 320 Request Info

    FDA Scrutiny of Promotion and Advertising - 2017

    Overview: DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertising methods and messages. The days of looking at text alone for a magazine insert are long gone. Why should you Attend: That is expensive and leaves you with a cloud over your name at the FDA. That is never a good thing. You must know what you are doing with DTC advertising, not just hope you do. You will probably earn a Warning Letter by "Winging it."