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Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

Hybrid seeds are developed by cross-breeding plants (two or more plants) of different species. Cross-pollinated will develop a seed that carries one or more desired traits. These seeds are widely used in farming (commercial) to increase yields and to develop climate and disease resistant plants. Moreover, these seeds are widely used in farming and gardening of vegetables and flowers such as sweet corn tomatoes, and roses. Hybrids are chosen to improve the characteristics of the resulting plants such as better fruit quality, better uniformity, heat and cold tolerance, early maturity, increased yield, etc. Increasing demand for vegetables and fruits from emerging economies is expected to increase the demand for hybrid seeds. Hybrid seeds are the major contributors to the rise in agricultural output since the 20th century. Several breeding companies are focused on developing the resultant crops resistant to diseases through extensive research and development activities. However, the development of such seeds may be hindered under adverse climatic conditions. In 2018, a German company launched a hybrid rice seed with robust tolerance to Brown Plant Hopper pests and Bacterial Leaf Blight. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/hybrid-seeds-increase-yields-and.html

The majority of deals are development stage whereby the licensee obtains a right or an option right to license the licensors monoclonal antibody technology. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

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 /

Course "The A to Z's of HIPAA Privacy, Security, and Breach Notification Rules" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. Who Will Benefit: * Information Security Officers * Risk Managers * Compliance Officers * Privacy Officers * Health Information Managers * Information Technology Managers * Medical Office Managers * Chief Financial Officers * Systems Managers * Legal Counsel * Operations Directors Agenda: Day One Day one sets the stage with an overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule Lecture 1: Overview of HIPAA Regulations * The Origins and Purposes of HIPAA * Privacy Rule History and Objectives * Security Rule History and Objectives * Breach Notification Requirements, Benefits, and Results Lecture 2: HIPAA Privacy Rule Principles, Policies and Procedures * Patient Rights under HIPAA * Limitations on Uses and Disclosures * Required Policies and Procedures * Training and Documentation Requirements Lecture 3: Recent and Proposed Changes to the HIPAA Rules * New Penalty Structure * New HIPAA Audit Program * New Patient Rights

Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion. Why should you attend: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta

Course "Texting and E-mail with Patients: Patient Requests and Complying with HIPAA " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are revolutionizing the ways health care providers interact with their patients and get their work done. But the use of these devices comes with hidden costs of compliance, especially if they lead to a reportable breach under HIPAA or state laws. HIPAA Privacy and Security Officers have been struggling to keep up with the use of the devices to protect patient privacy and avoid compliance issues. Even if these devices aren't in formal use in your organization, you need to act now to anticipate their use and make sure they are used properly. This session is designed to provide intensive, two-day training in HIPAA compliance as it relates to the use of mobile devices, including how to use them with Protected Health Information, the policies and procedures you need to have in place to use them securely, and how to manage issues of the "BYOD" phenomenon. The session provides the background and details for any manager of health information privacy and security to know what issues to look for with mobile devices, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. The session will be valuable for both newcomers to HIPAA compliance as well as seasoned veterans. HIPAA compliance will be explained and discussed in detail, from the basics through the latest changes and new technology issues, so that the attendee will have a coherent u

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

Overview: With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are revolutionizing the ways health care providers interact with their patients and get their work done. But the use of these devices comes with hidden costs of compliance, especially if they lead to a reportable breach under HIPAA or state laws. HIPAA Privacy and Security Officers have been struggling to keep up with the use of the devices to protect patient privacy and avoid compliance issues. Even if these devices aren't in formal use in your organization, you need to act now to anticipate their use and make sure they are used properly. This session is designed to provide intensive, two-day training in HIPAA compliance as it relates to the use of mobile devices, including how to use them with Protected Health Information, the policies and procedures you need to have in place to use them securely, and how to manage issues of the "BYOD" phenomenon. The session provides the background and details for any manager of health information privacy and security to know what issues to look for with mobile devices, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. The session will be valuable for both newcomers to HIPAA compliance as well as seasoned veterans. HIPAA compliance will be explained and discussed in detail, from the basics through the latest changes and new technology issues, so that the attendee will have a coherent understanding of not only the rules, but also how to think about compliance and make sound compliance decisions on a day-to-day basis in the context of mobile devices. Agenda Day One Day one sets the stage with an ov

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 / Senior

Utilizing small wheels and lighter materials, transport wheelchairs can tip the scale at as little as 19 lbs., ideal for those looking for a highly portable option. Transport chairs also tend to be more affordable and offer the benefit of increased mobility without breaking the bank. This type of lightweight wheelchair is often referred to as a "transfer chair" and is typically used for shorter trips. Since it's geared towards storability and portability, it features four smaller wheels and dispenses with the larger, rear-mounted wheels that characterize standard wheelchairs. Its construction ensures that it's always foldable and portable, but does so at the expense of self-propulsion. Instead, a transport chair is built so that a caregiver can easily push the user from point A to B. Transport Wheelchair features a lightweight aluminum frame with a multiple finish options. It comes standard with padded-permanent armrests and swing-away footrests with composite footplates. It is an ideal solution for easy transportation and storage. Karma KM 2500 Small Wheel Wheelchair: Karma KM 2500 Small Wheel Wheelchair Specifications: Width 18" Front/Rear Wheels 6" to 14" Seat Width 47cm Seat Depth 40cm Overall Width 66cm Overall Collapsed Width 36cm Armrest Height 21cm Overall Length 90cm Seat Height 47cm Backrest Height 38cm Overall Height 86cm Weight 9.2 k.g. Karma KM 2500 Small Wheel Wheelchair Seat and Back: AEGIS Microbe Shield Approved by the FDA, EPA, EU, etc., bonded anti-microbial barrier upholstery protects from odor, staining and deterioration from bacteria, fungus and other microorganisms. It is a shield for your health. Karma KM 2500 Small Wheel Wheelchair Extended Armrest: By simulating the natural position of arms, the extended armrest design is ergonomic and creates bigger seating space. An Ultra lightweight wheelchair (9.2 kg) with a compact design for either attendant assisted or self propelling users. The

Overview: In this session we will discuss the HIPAA audit and enforcement programs and how they work, and discuss the areas that caused the most issues in prior audits. We will explore what kind of issues and what kind of entities had the most problems, and show where entities need to improve their compliance the most. We will also explore the typical risk issues that lead to breaches of health information and see how those issues may be a target for auditors in the new 2016 audits. We will review the contents of the HIPAA Audit Protocol used in 2012 to show what documentation needs to be on hand should your organization be selected for an audit in the new round. We will present methods for using the contents of the HIPAA Audit Protocol to build your own compliance plan by extracting and updating the contents and relating your compliance activities directly to the questions that might be asked. In this session we will discuss the HIPAA audit and enforcement regulations and processes, and how they apply to HIPAA covered entities and business associates. We will explain the enforcement regulations and the new, increased fines and new penalty levels, including new penalties for willful neglect of compliance that begin at $10,000. We will discuss what information and documentation must be prepared in advance so that you can be ready for an audit at any time, including sample information request forms and questions asked at prior audits. The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to help limit your exposure. We will discuss how most enforcement actions come about and what can be done to prevent incidents that lead to enforcement activity. The HIPAA Privacy, Security, and Breach Notification regulations (and the recent changes to them) and how they will be audited will be explained. Documentation requirements for compliance will be explored and a framework of security policies necessary

Phenol formaldehyde resins or phenolic resins are synthetic polymers derived from the reaction between phenol and formaldehyde. Phenolic resins were known as the first commercial resins used in the production of molded products such as billiard balls and laboratory countertops. Phenolic resins are also used as adhesives and coasting. A wide variety of product types of phenolic resin are available in the market, such as formaldehyde-free phenolic resin, bio-phenolic resin, resole resin, cresol, and novolac resin. Furthermore, phenolic resins find major application in several industrial activities (such as wood-adhesive, friction materials, abrasives, fire retardants, hardeners, for insulation purposes, molding compounds, offshore oil drilling, laminates, etc.) owing to its properties such as high mechanical strength, adhesion, heat resistance, moisture resistance, etc. Increasing consumer awareness about the advanced properties of phenolic resin is expected to propel the growth of the market. Moreover, increasing demand for rubber and friction materials from the tire industry, which, in turn, has generated interest in durable and lightweight phenolic compounds, driving the growth of the phenolic resins market. The development of SpaceX Dragon Capsule's heat shield, a phenolic impregnated carbon ablator, is one of the most important technological innovations in the market. This enables the capsule to be reused for future missions, as the raw material allows spacecraft, crew, and cargo to safely return to Earth, despite the high temperatures. Read more @ https://sachinbhombe.blogspot.com/2021/03/asia-pacific-is-expected-to-witness.html

Biopharmaceuticals contract manufacturing refers to pharmaceutical companies outsourcing the development and manufacturing of drugs. It is driven by the use of advanced technologies, scientific advances, and d a highly complex research and development enterprise. It provide wide range of manufacturing services to biopharmaceutical companies. Biopharmaceutical contract manufacturing is widely used due to the complexity in manufacturing of biomolecules, as are considerably more complex, different in shape, size, and behavior than pharmaceuticals. Contract manufacturing organizations (CMOs) provide services from development of biologics to commercial scale production. Biopharmaceutical contract manufacturing involves the production of medicines in small units that can be customized to meet customer specifications. Contract manufacturers usually produce high quality and highly secure pharmaceuticals at low prices. The primary components of these drugs are plant materials and chemical substances. Biopharmaceutical companies are focused on producing numerous pharmaceuticals for the pharmaceutical industry. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/biopharmaceutical-contract.html

Biosimilars, also known as biologic products, are currently the fastest growing category of medical products in the United States, with sales estimated at more than $40 billion dollars annually. When prescribed by doctors, these products may provide more effective treatment options for patients suffering from a chronic disease or condition. In late August, the FDA held a forum on biosimilars. The topic was "biosimilar medications - what are they, how do they work, and are they safe and effective." Representatives from the FDA, pharmaceutical companies, and biotechnology organizations attended the forum. The forum included individuals who are leading the charge to register biosimilar products for clinical trials. According to the FDA, the agency will begin accepting applications for biologic drugs in late fall of 2020. In Japan, various manufacturers are focused on developing pipelines that contain biosimilar candidates aimed at treating various therapeutic conditions for patients in Japan. For instance, in December 2020, Alvotech and Japanese pharmaceutical company Fuji Pharma agreed on an extension on their exclusive strategic partnership for the commercialization of four biosimilar medicines in Japan. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/biosimilars-and-impact-of-covid-19.html

Micro guide catheters are used in order to guide the urethra so that you can have an easy time inserting your pet's urethra and not be worried about any kind of blockage at all. There are many types of these devices available in the market. Some of these are manual tube and electric as well. Many people prefer to use micro guide catheters because they are made very simple and with great ease of use. A growing number of surgical procedures for treating cardiovascular diseases is fueling the growth of the micro guide catheters market. According to the American College of Cardiology Foundation, in 2017, emergency medical services-assessed out-of-hospital cardiac arrest occurred in an estimated 356,461 Americans; emergency medical services treatment was initiated in 52%. In the United States in 2019, coronary events are expected to occur in about 1,055,000 individuals, including 720,000 new and 335,000 recurrent coronary events. The increasing development of modern disposable catheters that are safer and more comfortable to insert is further projected to foster the growth of the micro guide catheters market. North America is projected to gain significant growth over the forecast period and this is attributed to the continuous launch of innovative products by ley players in the region. For instance, in March 2017, Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and the U.S. commercial launch of the TrapLiner Catheter. The TrapLiner Catheter was developed by Vascular Solutions Inc., which was acquired by Teleflex. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/rise-in-number-of-cardiovascular.html

Overview: The webinar will concentrate on topics that HHS has announced will be the focus of the first round of "desk audits". They reflect significant areas of non-compliance revealed in the 2012 pilot audits and HHS HIPAA violation investigations concluded by Resolution Agreements and Corrective Action Plans. They include: HIPAA Risk Analysis Risk Management based on Risk Analysis Breach Notification Notice of Privacy Practices (for Covered Entities) Minimum Necessary Standard Access of Individuals to their PHI Authorizations Workforce Training This webinar is vital because, in focusing on preparation for a HIPAA Compliance Audit, Covered Entities and Business Associates may review, prioritize and structure their HIPAA Compliance programs. If you have HIPAA Compliance documentation ready to submit on two weeks notice to HHS you are implementing an effective HIPAA Compliance program. In addition, every Covered Entity or Business Associate may face an HHS HIPAA Compliance investigation at any time due to a complaint or a Breach. If you are "audit ready" you will be ready for an investigation - and better able to avoid complaints and prevent breaches. Why should you attend: Every Covered Entity and Business Associate is liable - without prior notice - to be audited for HIPAA Compliance by HHS You will have only 2 weeks after receiving your HIPAA Compliance Audit notification and data request to upload all requested documents to an HHS HIPAA Compliance Audit Portal The HIPAA Compliance Audit data request you receive will specify content and file organization, file names and any other document submission requirements Auditors will not contact an audited entity for clarifications or ask for additional information - it is essential that submitted documents are current, accurately reflect the entity's HIPAA Compliance program and demonstrate HIPAA Compliance Only data submitted on time will be assessed Failure to respond on time may be referred to the HHS regional

The business of providing professional services and/or/ staff augmentation to Healthcare organizations has become a fast-paced field which enables healthcare institutions to quickly learn and apply their knowledge to a variety of problems. This field requires fighting challenges that are crucial for the success of healthcare providers' clinical and commercial future, and yet are severely difficult to solve. Likewise, the pressure to consistently maintain high-quality services and performance is also affected by the occasionally shifting goals of clients.

Why buy an ice machine when you can rent one? Rent an ice machine for your hospital or any other medical facility today.