Skip to main content

Home/ Healthcare 2.0/ Group items tagged Reports

Rss Feed Group items tagged

Roger Steven

How to Handle HIPAA Security Incidents, Breaches, Complaints, and Investigations - 0 views

  •  
    Overview: This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also constitute a breach as the $4.2 million fine assessed against Cignet Healthcare of Prince George's County, Maryland, dramatically proved. Handling an investigation properly is key to determining not only how to handle it to mitigate any harm and to take action to prevent it from happening again but also to determine whether it is reportable to affected individuals and to DHHS. HIPAA requires a complaint procedure (policy). The webinar will suggest what such a document should contain as it also will for the required report procedure (what is reportable, who reports, to whom, and required/suggested contents of the report) and the required response procedure (what do the responsible officials do after receiving the report or the complaint). Investigating a possible security incident is key. The webinar will cover how to conduct a thorough investigation of HIPAA security incidents, breaches, and patient complaints. Finally, the second largest HIPAA civil money penalty or settlement, $4.2 million, was in large part due to the offender's failure to cooperate with the DHHS investigation. The presenter has successfully defended his clients in seven such investigations and knows how to respond to them to avoid or minimize liability. Think of a gap analysis as an examination of: What you currently have in place for HIPAA compliance. Is that adequate? Can it be done better? Is it enough? And what am I missing? Asking these questions will help establish the direction and next steps to take. It lays the ground work for a good Risk Analys
Roger Steven

How to Handle HIPAA Security Incidents, Breaches, Complaints, and Investigations - 0 views

  •  
    Overview: This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also constitute a breach as the $4.2 million fine assessed against Cignet Healthcare of Prince George's County, Maryland, dramatically proved. Handling an investigation properly is key to determining not only how to handle it to mitigate any harm and to take action to prevent it from happening again but also to determine whether it is reportable to affected individuals and to DHHS. HIPAA requires a complaint procedure (policy). The webinar will suggest what such a document should contain as it also will for the required report procedure (what is reportable, who reports, to whom, and required/suggested contents of the report) and the required response procedure (what do the responsible officials do after receiving the report or the complaint). Investigating a possible security incident is key. The webinar will cover how to conduct a thorough investigation of HIPAA security incidents, breaches, and patient complaints. Finally, the second largest HIPAA civil money penalty or settlement, $4.2 million, was in large part due to the offender's failure to cooperate with the DHHS investigation. The presenter has successfully defended his clients in seven such investigations and knows how to respond to them to avoid or minimize liability. Think of a gap analysis as an examination of: What you currently have in place for HIPAA compliance. Is that adequate? Can it be done better? Is it enough? And what am I missing? Asking these questions will help establish the direction and next steps to take. It lays the ground work for a good Risk Analy
Roger Steven

OSHA Injury and Illness Record Keeping - 0 views

  •  
    Overview: This webinar will explain the details of how to report and what to report on the OSHA Injury and Illness report. It will include an explanation of how to determine if an injury is work related, if an injury is new or ongoing, and what the differences are between first aid and medical treatment. A specific list of what constitutes injuries, illnesses and first aid treatment will be provided, along with practical examples of how to determine if an injury should be reported. In addition, examples of the forms used to report injuries, as well as annual summaries will be presented. Why should you attend: OSHA Injury and Illness Record keeping provides a window for regulators to see into your business to determine if the work environment is safe or if there are problems. Correct reporting of injury and illness data and a clear understanding of what to report and how to report it is a key necessity to avoid potential inspections and fines. Areas Covered in the Session: Injury and Illness reporting Determination of workplace relatedness Differences between first aid and medical treatment Determination of case as new or ongoing How to count total lost days Advantages that a company can provide to reduce risks of inspections and fines Who Will Benefit: Safety Personnel HR Personnel Managers Executives Speaker Profile Kenneth S. Weinberg is an independent consultant in environmental health and safety. Dr. Weinberg has consulted for several companies in the areas of OSHA Injury and Illness reporting, as well as auditing for OSHA inspections. He has worked as the Director of Safety at Mass. General Hospital in Boston for almost twelve years, and has written several books on the topics of health care safety, OSHA, and Indoor Air Quality. He has also written several articles for prominent national safety publications, and serves on the editorial advisory boards for safety publications. He Also has been Administrator of the Health Care Divisio0n of the American Socie
sachin_cmi

Medical transcription services has tremendously changed the way of delivering patient r... - 0 views

  •  
    Medical transcription services are health reports that are typed out from dictated medical reports by medical professionals, such as doctors, dentists, and physicians. These reports contain vital information regarding a patient's health and are crucial to their care. This service offers data accuracy and data-driven insights for making an easy decision regarding patient treatment and care. Medical transcription services can be classified into Discharge Summary (DS), History and Physical Report (H&P), Operative Note or Report (OP), Consultation Report (CONSULTS), and Pathology Report (PATH) & Radiology Report. Continuous advancement in the medical transcription services market is expected to drive the growth. For instance, in October 2020, ETranscription, a Canadian transcription company, launched its new website and platform to expand its high-quality transcription services. The company has offered a free trial and reduced rates to help hospital streamline their workflow. Moreover, updates support a seamless online transcription process while delivering secure, accurate, and cost-effective services. This service effectively reduces clinical documentation time and enables doctors to plan the patient's treatments. Increasing adoption of technologies such as digital health, telemedicine, and EHR is further anticipated to foster the growth of the medical transcription services market in the near future. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/medical-transcription-services-has.html
Roger Steven

The Sunshine Act: Reporting for Clinical Trials - 0 views

  •  
    Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act. Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Areas Covered in the Session: Purpose of the Sunshine Act Who is required to report under the Sunshine Act? What is reported? Exclusions Tracking Penalties Useful links Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research Clinical Research Coordinators Principal Investigators/Physicians Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fu
Roger Steven

The Physician Payment Sunshine Act - an understanding - 0 views

  •  
    The Physician Payment Sunshine Act: The Physician Payment Sunshine Act, also called Physician Payments Act, is a piece of legislation passed by the American Congress in 2010. It came to be enacted along with the Affordable Care Act, or Obamacare. The purpose of this legislation is to ensure transparency in the financial relationships that exist between the pharmaceutical industry, teaching hospitals, and physicians. What the Sunshine Act requires is this: Manufacturers of drugs and medical devices, and organizations that purchase in groups (Group Purchasing Organizations or PGO's) have to report payments or their equivalent that they make to physicians and teaching hospitals. Items that are considered equivalent to money payments, transfers of which have to be reported are clearly mentioned. These include the following: Meals Honoraria or grants Gifts Entertainment Speaking fees Writing services, such as research papers or manuscripts Travel reimbursements Purchase of items such as teaching materials and journals, which are paid either directly to physicians or teaching hospitals, supplied either directly or through a third party Funding for research Another core reporting requirement: Another requirement of the Sunshine Act is that when manufacturers of drugs and medical devices and group purchasing organizations have physicians who have a stake in some or another form in their organizations; this has to be reported to the Centers for Medicare and Medicaid Services (CMS). These reporting requirements apply to all kinds of physicians, who are either specialists or are general practitioners. However, the following are excluded from reporting by the Sunshine Act: Nurses Support and office staff Residents Medical students Physicians assistance Advance practice nurses Physicians need not report: The Sunshine Act requires information about these payments and transfers to be made by the paying medical device and drug companies, and not by physicians.
Roger Steven

Developing Hospital Billing and Chargemaster Policies and Procedures - 0 views

  •  
    Overview: Hospital chargemasters are complex and represent a key component for the revenue cycle of hospitals. Chargemasters are intertwined with coding for services, billing for services, charging for services and even involve the cost reporting process. A myriad of decisions must be made concerning how the chargemaster is organized, impacts on coding and billing, charge structuring, cost accounting, and other processes within the revenue cycle. Whenever decisions are made, policies and procedures should be developed, approved and implemented. A proper system of billing and chargemaster policies and procedures can help to maintain an appropriate compliance stance in a world where ambiguous guidance is often the norm. The development of charges and charge structuring within the chargemaster is a major issue often referred to as transparent pricing. While even the Medicare program maintains that hospitals should charge for everything, the way in which charges are set and amalgamated at the claim level can vary significantly between hospitals. A key issue for the chargemaster is differentiating separately charging from separately reporting. The way in which hospitals make decisions about the bundling of charges at the line-item level within the chargemaster leads to many decisions, all of which need justification through proper policies and procedures. Due consideration must be given to departmental concerns about revenue generation, cost reporting implications, coding implications and any associate challenges with billing and claims filing. Why should you Attend: See Typical Questions - Here are some reworded marketing questions: Why are the chargemaster and hospital billing targets of compliance audits? How should we prioritize statutory and contractual compliance for the chargemaster and billing process? Will chargemaster and associated billing policies and procedures give us protection relative to compliance? How should we develop a system of chargemaster po
Roger Steven

PQRS in 2016 - Keys for Success - 0 views

  •  
    Overview: This webinar will cover the changes to the PQRS program in 2016 and will provide tips and strategies to help you select the best measures and reporting approach for your practice. Why should you Attend: Your future Medicare payments are at risk. Failing to report quality measures to CMS for Calendar Year 2016 will result in a reduction of up to 6% in your 2018 Medicare payments. The PQRS program carries a potential 2% penalty for each provider who does not report quality measures to CMS - physicians, mid-level providers, therapists, psychologists, social workers, even dieticians. In addition, if your practice has physicians and mid-levels, at least half the physicians must meet the PQRS requirements or the group will face an additional 2-4% penalty from the Value Based Modifier program. Areas Covered in the Session: Understand the difference between a reporting rate and a performance rate? Get access to useful tools to help you identify measures applicable to your specialty. Learn how to choose among the various reporting approaches - what are the pros and cons of each. Understand how CMS will evaluate your submission if you report less than 9 measures. Who Will Benefit: Practice Administrators All providers who bill to Medicare including Physicians (All specialties), Podiatrists, Physician Assistants, Nurse Practitioners, Psychologists, LCSW, Physical and Occupational Therapists, Speech/Language Pathologists, etc. Quality Officers Nurse leaders Finance Directors Speaker Profile Jeanne J. Chamberlin Jeanne Chamberlin is currently a Practice Management Consultant with MSOC Health. During her 30 years in the healthcare industry, Jeanne has worked in independent medical practices, health systems, state government, and software development. She holds a Masters Degree in Public Policy from Duke University and is a fellow in the American College of Medical Practice Executives. She has been a leader in both state and local MGMA chapters. As practice ad
Roger Steven

Clinical Documentation Improvement - 0 views

  •  
    Overview:   Review 6 points of high quality evidence based clinical documentation Review of 7 criteria that all entries in a patient record should include Impact of documentation on coding and claims Impact on audits and ability to defend an audit When an audit is initiated, the completeness of documentation becomes critical in the ability to support what you have reported. Let's take a look at areas in which weaknesses are often found.  Why should you Attend:  The granularity and accuracy of the ICD-10 code set is supported by quality clinical documentation. It is anticipated that payers will increasingly become less flexible in allowing non-specific codes. The use of unspecified codes will likely lead to rejected claims if it is possible to report the more definitive condition. In most cases, unspecified should not be reported unless there is clear evidence to support the inability to report the detailed option.  Is your E & M level supported in the documentation? If you have never experienced scrutiny of your billing patterns by payers and other entities, you may not be aware of weaknesses that lead to recovery of funds or other costly consequences. Your documentation will be key in supporting diagnoses, service codes and acuity of the patient. It is not just payers who engage in audits. Others include State medical boards, Qui Tam and possible reporting of questionable practices by patients. Do your billing patterns and documentation stand up under reporting scrutiny? This presentation will review areas in which you may not be as strong as you think!  Areas Covered in the Session: Significance of abnormal lab results Measurement of lesions, when taken and inclusion of margins Start & stop times & methodology for infusions & discrepancies in billing Diagnostic testing and medications should be supported in a diagnosis Depth of wounds and cause should be clear Severity of illness Diagnosis present on admission? Who Will Benefit: Coders Billers Rev
lifelinelab

Delhi Base Pathology Lab Near Me - 0 views

Lifeline laboratory are designed to identify the disease or illness of the humans on the basis of symptoms. Basically, humans get the physical test done in pathology labs on the behalf of doctors&...

Bestpathologylabs bestpathlabnearme Bestdiagnosticlab diagnosticcenternearme bestdiagnosticcenternearme diagnosticcenter bloodtestathome bloodtestathomenearme bloodonlinetest onlinebloodtest onlinebloodtestlabindelhi thyroidtestathome thyroidtestlabnearme

started by lifelinelab on 10 Oct 18 no follow-up yet
Roger Steven

ICD-10 and Other Factors Affecting Your Cash Flow - 0 views

  •  
    Overview: As the healthcare industry moves toward a value based reimbursement model rather than fee for service, it is crucial that the provider and ancillary staff understand how ineffective reporting can lead to dollars lost. We will review the 3 critical areas that require skilled management. Understand that patients are more educated about their healthcare and are increasingly responsible for more out of pocket costs. High dollar deductibles may result in self pay realities and bad debt increases. Learn areas that increase your chances for an audit. Are you ready for the challenge? Why should you Attend: Revenue is dependent upon proficiency in multiple areas. In today's environment, it is risky to maintain the status quo and increasingly important to obtain and maintain skilled business staff. The granularity of the ICD-10 code set requires understanding of the official coding conventions and guidelines, the ability to apply those guidelines, and the ability to recognize when reporting may lead to revenue delay, reduction or loss. Additionally, other factors affect your revenue stream. This includes patients with high deductible plans, collection of much more than a small co-pay, and staff understanding of regulations that govern telephone collection activity. Don't leave money on the table or invite an audit into your practice. Audits are often the result of weak billing and coding skills. This program will review several areas that will cost you money if poorly handled. Areas Covered in the Session: Required specificity in coding Documentation necessary for ICD-10 reporting Why coders must frequently query for clarification How ambiguous diagnosis reporting affects you r bottom line Internal collections versus outsourcing. What should you consider Staff effective in handling problem claims? Developing appeals? Who Will Benefit: Coders Billers Revenue cycle Physicians Mid-level providers Nurses Claims follow-up Managers Managers Speaker Profil
wjack1475

Global GPS Receiver Market Research Report 2017 - 0 views

  •  
    In this report, the global GPS Receiver market is valued at USD XX million in 2016 and is expected to reach USD XX million by the end of 2022, growing at a CAGR of XX% between 2016 and 2022. Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), market share and growth rate of GPS Receiver in these regions, from 2012 to 2022 (forecast), covering North America Europe China Japan Southeast Asia India
Roger Steven

HIPAA Breach Notification Rule - What You Must Do To Comply - 0 views

  •  
    Overview: Final regulations for the new HIPAA Breach Notification Rule require much more than notifying individuals affected by a Breach of their Protected Health Information (PHI). Covered Entities and Business Associates first must follow and document a very specific process to determine if a Breach occurred. If no Breach occurred documentary proof must be kept for six years. If a Breach did occur timely notifications and other actions must be undertaken and documented. This webinar will explain: What Covered Entities and Business Associates must do to comply with the Breach Notification Rule What is and is not a Breach Three exceptions - when an acquisition, access, use, or disclosure of PHI not permitted by the Privacy Rule is not a Breach How to perform a Breach Risk Assessment to determine if you can demonstrate a a low probability that the PHI was compromised Who must be notified in case of a Breach When notifications must be provided What information must be contained in each notification Other requirements in case of a Breach Investigate Mitigate harm to affected individuals Protect against further Breaches Document everything Planning and preparation for the worst - public relations and mitigation strategies to limit damage to the organization's reputation and financial well-being Why should you attend: Breaches and incidents that might be Breaches happen all the time! More than 173,000 separate breaches of Protected Health Information (PHI) affecting less than 500 individuals were reported to the U. S. Department of Health and Human Services (HHS) between September, 2009 and May 31, 2015 and in the same period HHS received approximately 1240 reports of PHI breaches that affected 500 or more individuals An acquisition, access, use, or disclosure of PHI not permitted by the Privacy Rule is presumed to be a Breach unless it falls within an exception or the Covered Entity or Business Associate can demonstrate a low probability that the PHI was compromi
Roger Steven

New HIPAA Rules - Meeting Requirements for New Patient Rights and New Restrictions on D... - 0 views

  •  
    Overview: New changes modifying the HIPAA Privacy and Security Regulations are going into place to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. The changes include establishing new rights for individuals as well as changes to the limitations on uses and disclosures. New requirements for patient access to records and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restriction and accounting of disclosures and increased enforcement activity. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs. And if you are required to have a HIPAA Notice of Privacy Practices, you will need to update that to show all the new rights that patients will have, such as electronic copies, new rights to restrict disclosures, and much more. Business associates are now directly covered by the HIPAA privacy and security regulations and are liable for fines and penalties if they do not comply. If a business associate supplies services that interact with the new changes to the rules, the BA will need to be aware of the new requirements. We will explain what a Business Associate needs to do differently under the new regulations. Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information - the electronic age in health care brings new obligations to serve individuals as well as manage health information for healthcare professionals. We will discuss how disclosures must be tracked in an EHR and review the various ways patient records can be supplied electronically. The new regulations will be reviewed and their effects on usual practices will be discussed, as will what policies need to be chang
Roger Steven

Dealing with Medicare and Medicaid Overpayments - 0 views

  •  
    Dealing with Medicare and Medicaid Overpayments : Medicare and Medicaid overpayments are pretty common. If they are not dealt with properly, they invite penalties. Medicare and Medicaid Overpayments happen when a person, provider or supplier receives a payment that is in excess of the amount due to him or her under Medicare statutes and regulations. This overpayment becomes a federal debt that is owed by the individual to the State. So, Centers for Medicare and Medicaid Services (CMS) is required by federal law to recover this amount. Overpayments routinely occur in Medicare and Medicaid. Many a time, these are unintended and are usually a result of oversight, but could also happen due to intent. Some of the most common reasons for which Medicare and Medicaid overpayments occur can be when: Duplicate submissions of the same service or claim are made Excessive or non-covered services are billed or furnished for billing Services that are not necessary medically or are excluded are paid for The wrong payee gets paid. How are Medicare and Medicaid overpayments processed? Obamacare has amended the federal False Claims Act (FCA), which is part of the Fraud Enforcement Recovery Act of 2009 (FERA), to add provisions relating to recovery of Medicare and Medicaid overpayments. This is how the process of Medicare and Medicaid overpayments works: Whenever Medicare comes to know that any overpayment of $10 (raised to $25 from July 2014) or more is made, it directs the Medicare Administrative Contractor (MAC) to initiate the process of recovery of this overpayment. The MAC starts the process by initially mailing a demand letter in which repayment is requested If no action is taken, a second and third demand letters are mailed in a month following the first one. Contents of a demand mail from Medicare/Medicaid: The demand letter sent by the MAC will explain the details of the Medicare and/or overpayment. When repayment is not made in full within 30 days, interest starts get
sachin_cmi

Emergence of Covid-19 to Augment Growth of Online Retail Market - 0 views

  •  
    Increasing adoption of smartphones is expected to propel growth of the global online retail market. For instance, according to Pew Research Center, as of February 2019, 81% of U.S. adults used smartphones compared to 77% in October 2018. Moreover, increasing penetration of internet is also expected to aid in growth of the market. For instance, according to China government-backed Market Intelligence & Consulting Institute and reported by China Internet Watch, internet penetration in China reached 61.2 percent in the first half of 2019, with 854 million internet users at the end of June 2019. Emergence of Covid-19 is expected to offer lucrative growth opportunities for players in the global online retail market. For instance, in July 2020, Columbia Sportswear Company reported a 40% decline in overall net revenues in its July 2020 quarterly earnings report, due in part to pandemic-related store closures. However, the company's e-commerce sales increased 72% compared with the year-ago period. Moreover, increasing expenditure on personal care products is also expected to aid in growth of the market. For instance, according to the U.S. Bureau of Labor Statistics, average annual expenditure on personal care products in the U.S. increased from US$ 707 in 2016 to US$ 768 in 2018. Among regions, Asia Pacific is expected to witness significant growth in the online retail market. For instance, according to India Brand Equity Foundation, the e-commerce sector in India is expected to reach US$ 200 billion by 2026 from US$ 38.5 billion as of 2017. The market is also driven by significant growth in the FMCG sector. For instance, according to India Brand Equity Foundation, FMCG market in India is expected to grow at a CAGR of 27.86 per cent and is expected to reach US$ 103.70 billion by 2020 from US$ 52.75 billion in FY18. Read More @ https://coherentmarketinsights-blog.blogspot.com/2020/11/emergence-of-covid-19-to-augment-growth.html
wjack1475

Global Pet Food Ingredients Industry Market Research 2017 - 0 views

  •  
    In this report, we break down the Pet Food Ingredients industry from two angles. One section is about its creation and the other part is about its utilization. As far as its generation, we dissect the creation, income, net edge of its primary producers and the unit value that they offer in various districts from 2012 to 2017. As far as its utilization, we break down the utilization volume, utilization esteem, deal value, import and fare in various locales from 2012 to 2017. We likewise make an expectation of its generation and utilization in coming 2017-2022.
P3 Healthcare Solutions

How to Explore MIPS 2020 Through Improvement Activities? - 0 views

  •  
    This program has combined previous quality reporting programs such as Physician Quality Reporting System (PQRS), Value-based Payment Modifier (VM), and the Electronic Health Records (EHR) Incentive program (Meaningful Use) under one platform.
  •  
    This program has combined previous quality reporting programs such as Physician Quality Reporting System (PQRS), Value-based Payment Modifier (VM), and the Electronic Health Records (EHR) Incentive program (Meaningful Use) under one platform.
Bharatbookbureau MarketReport

Proteomics - Technologies, Markets and Companies - 0 views

  •  
    Proteomics - Technologies, Markets and Companies"describes and evaluates the proteomic technologies that will play an important role in drug discovery, molecular diagnostics and practice of medicine in the post-genomic era - the first decade of the 21st century. http://www.bharatbook.com/market-research-reports/healthcare-market-research-report/proteomics-technologies-markets-and-companies.html
Roger Steven

Seminar on Validation and 21 CFR 11 Compliance of Computer Systems Intermediate to Adva... - 0 views

  •  
    Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend : * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors /
1 - 20 of 235 Next › Last »
Showing 20 items per page