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  • 1 Request Info

    Overview of Device Regulation - FDA 2017- Before 30 April 50% Discount for its All Seminars

    This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways. Read More :
  • 2 Request Info

    Risk Management in Medical Devices Industry 2017- Before 30 April 50% Discount for its All Seminars

    Gaps, incorrect or incomplete implementation of software 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 device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software. Read More:
  • 3 Request Info

    HIPAA Compliance for Small Healthcare Providers 2017- Before 30 April 50% Discount for its All Seminars

    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:
  • 4 Request Info

    Writing and implementing effective SOP's 2017- Before 30 April 50% Discount for its All Seminars

    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. Even a standardized method, such as an ASTM or IP method, is insufficiently written to pass as a well-written and compliant SOP. The reasons why will be described, as will the steps needed to convert a standard method into an SOP. Read More:
  • 5 Request Info

    Laboratory, Medical and Device Performance and Validation following Regulatory 2017-Before 30 April 50% Discount for its All Seminars

    This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control. One also considers ICH Q8 and Q9. These techniques covers both clinical and laboratory applications. This applies to many areas such as stability testing, outlier analysis and risk management. It is not a course in statistics but introduces the participant to an applied approach to the statistical techniques one uses, how they are reasonably interpreted. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations. Read More :
  • 6 Request Info

    HIPAA Compliance Training 2017- Before 30 April 50% Discount for its All Seminars

    This two day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The second part of the first presentation is an overview of how to manage the HIPAA compliance project. At the end of these presentations there will be a workshop to demonstrate how to use these tools. Read More :
  • 7 Request Info

    Audit Like the FDA Audit Like the FDA 2017- Before 30 April 50% Discount for its All Seminars

    This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well planned audit program can reduce these risks. Read More :
  • 8 Request Info

    How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

    A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal documents that are prescriptive, and set a particular path on which the organization manages its day-to-day operations. A management system can be for one function, but more often than not, it incorporates many functions. Functions like accounting, engineering, banking, etc. have their own management systems, and the Safety, Health and Environmental, as well as Training and Security should have their own management system. This brings efficiency, consistency, cost effectiveness and timeliness to the entire process. Read More :
  • 9 Request Info

    Quality by Design using Design of Experiments (QbD) 2017

    This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents. Using a QbD approach for pharmaceutical development studies should include a systematic understanding of the process and using this understanding to establish a control strategy as part of a comprehensive quality risk management program. Read More:
  • 10 Request Info

    Why is FDA at my facility, and what do I do during an inspection 2017

    Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Read More:
  • 11 Request Info

    The Complete Payroll Law and Best Payroll Service 2017

    This course covers a very broad range of topics from worker classification, to employee classification, to establishing methods and rates of pay, what must be included in the rate of pay, hours that must be compensated as worked time, required benefits, de minimus working fringes, withholdings and deductions from pay, voluntary deductions, child support and garnishment orders, payroll reporting, analysis of risks of noncompliance, proper documentation of your policies and procedures and record retention requirements. We will show where to find the laws, how to interpret them and how to apply them in the most effective ways. Read More :
  • 12 Request Info

    Master HIPAA Compliance in Six Steps

    Overview: The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them. Seminar Takeaways: Thorough Understanding of HIPAA Rules • What they are • How they work together • Why and How they were made • How they are changing and what to expect next HIPAA Risk Analysis - Risk Management for Your Organization • A Practical Guided Exercise done in class on your computer to take home Privacy and Security Rules - Permitted and Required Uses and Disclosures • What information must be protected • Administrative, Technical and Physical Safeguards • Social Media, Texting and Emailing Patients Venue: The Doubletree Baltimore-BWI Airport Address: 890 Elkridge Landing Road - Linthicum, MD 21090
  • 13 Request Info

    Seminar on Preparing to Comply with the New FDA FSMA Rules – GlobalCompliancePanel 2016

    Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but if your data does not prove that you are actually preventing food safety problems, the plan is not considered valid and your overall food safety effort will fail audits. According to the FDA all food facilities "must monitor their controls, conduct verification activities, provide hard data to validate that the controls are effective, take appropriate corrective actions, and maintain records documenting these actions". This training session will present a practical approach to provide you and your team members with needed understanding and tools and a basic strategy for designing, implementing and validating preventive process controls. Venue: DoubleTree by Hilton Hotel San Francisco Airport Address: 835 Airport Blvd., Burlingame CA 94010-9949
  • 14 Request Info

    FDA Concepts for Medical Device Companies - Regulations, Myths, Challenges, and Best Practices – GlobalCompliancePanel 2016

    This seminar will show you how to structure and optimize your QMS. It all starts with Management Responsibility and a commitment to quality. We'll discuss the concepts of management responsibility, a culture of quality, and continuous improvement. We'll discuss tools and metrics for understand the state of your QMS and how to identify and prioritize opportunities for improvement. We'll discuss the 4 major Quality System elements that are emphasized by the FDA in their QSIT (Quality Systems Inspection Technique) inspections. Throughout the seminar, we'll emphasize the regulatory expectations and how you can translate them into your QMS. In each section, we'll cover lessons learned from recalls, 483s, and warning letters. We'll discuss myths and challenges and how you can avoid common problems. And will discuss best practices that you can easily adopt and will set you off on the right foot.
  • 15 Request Info

    Statistical Process Control & Process Capability – GlobalCompliancePanel 2016

    This course teaches participants the fundamental concepts and methods needed to establish effective control charts and estimate process capability. In addition to learning traditional control charts (e.g. xbar, r/s), participants will be exposed to other useful charts for handling multiple sources of variation (within/between) and short production runs. Practical aspects of implementing SPC on the shop floor are also discussed. Estimating process capability for both normal and non-normal data is discussed. The meaning and limitations of popular capability are presented in detail. This highly interactive course will allow participants the opportunity to practice applying SPC techniques with various data sets. The objective is to provide participants with the key tools and knowledge to be able to apply the methods effectively for their own processes. Venue: The DoubleTree Baltimore-BWI Airport Address: 890 Elkridge Landing Road - Linthicum, MD 21090
  • 16 Request Info

    Seminar on What You Need to Do to Prepare for a Successful Inspection

    .The seminar will provide an in-depth overview of the various enforcement actions, with primary focus an emphasis on Warning Letters, Seizures, Injunctions and Prosecutions.The Seminar will provide all details relevant to Pre and Post-Inspectional activities, tactics, strategies and is a must for those who have never gone through an FDA inspection and as a "refresh" for those who have to ensure your "state-of-readiness" and being prepared.
  • 17 Request Info

    Medical Device Complaint Handling

    In this two-day workshop you will understand all the processes and elements in a Quality Management System (QMS) that come to bear on effective Complaint Management. It starts with the definition of a complaint in FDA's Quality System Regulation (QSR) and ISO 13485:2003. (The complaint definitions are not the same.) In these systems a complaint has a specific technical meaning that is significantly different from the colloquial meaning.
  • 18 Request Info

    Baltimore Seminar on HIPAA Upcoming Changes

    This seminar will go into great detail about what is going on in the HIPAA Security/ Privacy world. I will discuss why the government is all of a sudden going full bore in demanding compliance. You will learn risk factors to avoid, best practices you should be doing, and how to be proactive in your efforts. In addition we are going to be discussing the methods in which patients can now sue under HIPAA and the steps they may be taking for civil remedy. On top of that what your practice or business needs to do so you can avoid the situation all together. I will explain what is involved in a HIPAA audit, how it is done, why it is being done, risk factors, how to avoid an audit altogether, and what to expect if audited (from real life experience). We will travel through time and see how the legislation has progressed, why it was benign somewhat in the past, and where we are now.... All the way from the inception in 1996 to the current Omnibus Ruling.
  • 19 Request Info

    Baltimore Seminar on Medical Device Complaint Handling

    In this two-day workshop you will understand all the processes and elements in a Quality Management System (QMS) that come to bear on effective Complaint Management. It starts with the definition of a complaint in FDA's Quality System Regulation (QSR) and ISO 13485:2003. (The complaint definitions are not the same.) In these systems a complaint has a specific technical meaning that is significantly different from the colloquial meaning.
  • 20 Request Info

    "90 Days to a Higher-Performance Team!

    Would you like your team to perform on all cylinders, like a well-oiled machine? Would it help to significantly improve your team's effectiveness and efficiency? Is it worth your time to improve your team's morale, motivation and productivity, saving you hours, days and weeks of lost time, energy and frustration? If you answered "yes" to any of these questions, then come laugh, listen and learn as Chris DeVany leads us all through those important topics, key questions and answers we all need to be able to address effectively to improve our team member's and team's performance! By attending, you will understand how to even more effectively: Organize your team into one strong, cohesive, high-functioning unit Streamline processes to reduce redundant work, save money, and ensure that everyone understands their roles Deal with troublemakers, underperformers, department rivals, bosses from hell, and other personality types Improve your team's morale and motivation-and watch productivity