Health and Environment Training Classes

The pharmaceutical industry has seen an increase in the number of biologics released to fight human disease. Large molecule therapeutics requires additional consideration when developing and validating supporting methods. This webinar will address steps to consider when developing bioassays with the expectation of successful completion of validation. Specifically, this webinar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. Specific topics covered in the webinar will include cell culture, multitrack development strategies, DOE, assay variability, and the validation protocol. Attendees will receive information that should be beneficial in helping to achieve well-controlled validated bioassay methods.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://onlinecompliancepanel.com/webinar/BIOASSAY-DEVELOPMENT-AND-METHOD-VALIDATION-5045

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

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

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

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

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

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

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: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901134SEMINAR?trainingregistry-December-2017-SEO

We all have medical issues from time to time and sometime we need something over the counter or stronger that is prescribed by a physician. Though, the use of prescription drug is quite legal, the warning on the label always mentions not to operate heavy machinery while taking such medications. The risks are loud and clear. So, when can you as an employer regulate something that might be completely legal? When can an employer require an employee to disclose his/her medications and what an employer needs to do?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/MEDICAL-MARIJUANA-AND-OTHER-PRESCRIPTIONS-508435/OCTOBER-2017-ES-TRAININGREGISTRY

The Stark law generally prohibits physicians from referring Medicare patients for Designated Health Services ("DHS") to an entity the physician or immediate family member has a financial relationship with, unless an exception applies. Under Stark, there is an exception known as the Non-Monetary Compensation ("NMC") exception (42 C.F.R. 411.357(k) that allows DHS entities that are the recipient of Medicare DHS referrals to provide certain non-cash items or services to a physician, up to $398 for 2017. This dollar amount threshold is adjusted each year for inflation.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/HOW-TO-TRACK-GIFTS-TO-PHYSICIANS-COMPENSATION-RULE-504946/OCTOBER-2017-ES-TRAININGREGISTRY

Overview: Nurse practitioners and physician assistants will enhance the efficiency and productivity of the practice to increase profitability. This Webinar will teach management of extenders to reduce costs, increase efficiency, retain patient satisfaction with services, yet reduce malpractice exposure. Primary care physicians and specialists can benefit from the use of physician extenders. Why should you Attend: Physicians performing all tasks is like engineers changing sparkplugs. Advanced Practice Clinicians ( APC, PA, NP) can extend and expand the practice, prevent burnout and increase profitability for the physician or group. Price - $139 Contact Info: Netzealous LLC -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com Website: http://www.mentorhealth.com/ Webinar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsorship/

Today health information needs to be shared more than ever, but how can that be done most easily within the limits of HIPAA? One way is to de-identify the information. Once PHI has been de-identified, it is no longer protected under HIPAA and may be shared freely without limitation. The problem is that it is not easy to truly de-identify information and if it is not done correctly, the sharing of the information may be considered a breach that requires reporting to HHS and the potential for penalties and corrective action plans. De-identification of Protected Health Information requires removing all eighteen of the listed identifiers, or anything else that might be used to identify the individual about whom the information exists. Or you can have an expert certify that the information is not identifiable. But neither of these is foolproof. Contact Info: Netzealous LLC -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com

Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but 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 understanding the fundamentals of a HIPAA compliance. If your healthcare practice, business, or organization needs to understand what is required to protect health records or make sure your current safeguards are adequate and can withstand government scrutiny, please join us for this informative and interactive course. Contact Info: Netzealous LLC -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com Website: http://www.mentorhealth.com

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

Medical device manufacturers need to establish statistical methods to understand and improve process capability and product characteristics. These could take many forms, because there are a variety of techniques available. The application of the tools is not always clear. Incorrect choices, inadequate descriptions, or incorrect implementation can result in missed opportunities or, at worst, an FDA Warning Letter.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/LINEAR-REGRESSION-MEDICAL-DEVICE-MANUFACTURERS-502580/OCTOBER-2017-ES-TRAININGREGISTRY

Overview: Understanding TIR 45 can be the roadmap for improving development and benefiting everyone, companies, development teams, caregivers, patients, and regulators. Why should you Attend: Perhaps you're a development manager, hoping to improve both productivity and quality. Or you are a quality assurance manager, facing a demand from management and development to permit a move to Agile.

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.

This webinar explains the inter-connected Breach Notification Rule requirements of Covered Entities and Business Associates when a Business Associate or Subcontractor Business Associate suffers a Breach. And it covers the special, more restrictive compliance requirements when a Business Associate or Subcontractor is an Agent under the Federal Common Law of Agency - including how to avoid creating an agency relationship by mistake.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/HIPAA-REACH-NOTIFICATION-FOR-COVERED-ENTITIES-AND-BUSINESS-ASSOCIATES-505808/OCTOBER-2017-ES-TRAININGREGISTRY

OSHA requires that businesses maintain a running account of injuries and illness that occur in the workplace. The logs must be completely and accurately filled in and completed. At the end of the year, these figures must be reported to OSHA or other report collection agencies to determine if the rate of injuries and illnesses falls within the norm for that industry sector.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/OSHA-RECORDKEEPING-COMPLIANCE-THE-NUTS-AND-BOLTS-OF-COMPLETING-THE-OSHA-300-Log-502949/OCTOBER-2017-ES-TRAININGREGISTRY

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