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Course "Risk Analysis and Design of Experiments (DOE) in Process Validation and Development" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. DOE is an extremely efficient method to understand which variables (and interactions) affect key outcomes and allows the development of mathematical models used to optimize process and product performance. The models also provide an understanding of the impact of variability in controllable and uncontrollable factors on important responses. The concepts behind DOE are covered along with some effective types of screening experiments. Case studies will also be presented to illustrate the use of the methods. This highly interactive course will allow participants the opportunity to practice applying DOE 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 in their process and product development efforts. Why should you attend: · Plan and conduct experiments in an effective and efficient manner · Apply good experimental practices when conducting studies · Determine statistical significance of main and interaction effects · Interpret significant main and interaction effects · Develop predictive models to explain and optimize process/product behavior · Check models for validity · Utilize models for one or more responses to find optimal solutions · Apply very efficient fractional factorial designs in screening experiments · Apply response surface designs for

Construction Safety Orientation Construction Safety Orientation is part of Occupational Safety and Health Administration (OSHA)'s safety initiatives for those employed in the construction industry. Construction Safety Orientation is offered to employers and employees in the construction industry by OSHA or its authorized trainers. Construction Safety Orientation is offered as either a 10-hour or 30-hour course to employees by OSHA-authorized trainers. The aim of the Construction Safety Orientation training is provide training to employees and employers in this industry to help them recognize, abate, avoid, and prevent injuries in the workplace. In addition, Construction Safety Orientation also involves providing training to the employees and employers about their rights and duties at the workplace. s Outreach Training Program is voluntary There are two reasons for OSHA recommends Construction Safety Orientation: OSHA's Outreach Training Program is voluntary; OSHA's Outreach Training Program, being basic, does not provide the full training requirements that the employer has to meet under set OSHA standards. Because of this reason, OSHA's Outreach Training Program is not considered a certification. The need for Construction Safety Orientation The sheer size of the American construction industry is the best reason for the need for Construction Safety Orientation: A little over two percent of the entire American population - something like 6.5 million people are engaged in the construction industry at more than a quarter of a million construction sites across the nation. This perhaps gives some perspective of the magnitude of the tendency for injuries and deaths in this industry. In fact, it is known that construction accounts for the highest rate of fatal injuries among all industries in the US. In a construction workplace, workers could be prone to almost any kind of injury or hazard. According to osha.gov, the most common reasons include: Falls (from heights);

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

Basics of the Anti-Kickback Statute : The Anti-Kickback Statute is aimed at curbing abuse and fraud in the Medicare and Medicaid systems by professionals who offer services and benefit in direct or indirect ways. In order to protect Medicare and Medicaid patients, as well as federal health care programs from abuse and fraud; the Anti-Kickback Statute was enacted. The core act that the Anti-Kickback Statute considered as fraud and abuse is the unlawful acceptance or diversion of money into influencing medical decision-making. The Anti-Kickback Statute is very clear on this. It states that anyone in the healthcare industry, who consciously and deliberately accepts a fee or remuneration of any kind or offers the same with the intention of manipulating the course of a medical decision-making, is liable to punishment. What acts attract penalties? Acts of various kinds attract penalties under the Anti-Kickback Statute. Some of these include: Carrying out advertising or marketing activities for promoting the brand of health care providers Participating in affiliate programs or pay per click commissions Working out promotion agreements with multiple companies Taking part in sponsorships Working out strategic alliances with healthcare providers Licensing content or technology Selling a healthcare provider's brands of products or services Taking a cut in the advertising revenue The nature of penalties under the Anti-Kickback Statute The Anti-Kickback Statute states major penalties for acts it prohibits. The Anti-Kickback Statute prescribes these major penalties: Up to five years in prison This has the potential to attract additional monetary fines of up to $25,000 Administrative civil money penalties that can go up to $50,000 In addition, the Office of Inspector General (OIG) could initiate administrative proceedings and take steps aimed at prohibiting anyone convicted of an Anti-Kickback violation from participating in State and federal programs. The OIG could also impose

We will start the event with a look back at HIPAA. Often times, the basics get overlooked or forgotten, often at the expense of increasing risks of a breach. This session will start at the grass roots level and work forward to today. It will include components of HIPAA, HITECH, Fines and Penalties, ICD-10, Meaningful Use, etc. We will also explore the breach statistics involving PHI, causes of breaches, etc. We will also examine how to mitigate the risks to your organization. We will also discuss effective staff training. Having a bad training is actually worse that having no training, and we will discuss the critical components that all employees should know and understand.

Ergo Wheelchair features an ergonomic "S" shaped seat that provides the perfect shape to fit the human body to relieve pressure, increase stabilization, weight distribution and lower the risk of pressure sores and scoliosis. Ergonomic wheelchair series provides users with a large selection of ultra lightweight wheelchairs that can help improve life. This series has features that include a high strength lightweight frame, foldable and easy to store, breathable anti-bacterial, anti-staining, removable and machine washable cushion. Also includes the exclusive S-Shape Seating System, which provides increased stability, better weight distribution and lowers the risk of pressure sores and spinal injury. Karma S Ergo 115 Wheelchair: This model features our S-Shape Seating System and is our number one best seller for many reasons. At a mere 11.3 kg in weight with detachable foot rest and many features such as removable machine washable and dry-able cushions treated by AEIGIS treated anti-microbial coated seating system. Karma S-Ergo 115 Wheelchair Features: Ergonomic Handrims & S-Shape Ergonomic Seating System Fixed armrest w/ wider concave armpads Swing In & Away Footrests Backrest Pouch attached to the upholstery 24" flat free polyurethane tires, high tread, flat free wheels Seat width: 16"x17" or 18"x17" or 20"x 17" Silver 1/4" Aegis Anti-Bacterial Upholstery, washable Folding backrest / folding seat for easy traveling "Tube-in Center" foot-plate, assures better side leg support High strength, starting weight at only 11.3 kg. (w/o footrests) 7×1" Polyurethane front casters Upholstery: Black breathable mesh bottom & top AEIGIS Frame Color: Pearl Silver or Rose Red Weight Capacity of 115 kg. Karma S-Ergo 115 Wheelchair Measurements: Seat Width 16 inch., 18 inch., 20 inch. Seat Depth 17 inch. Armrest Height 8 inch. Seat Height 19 inch. Back Height 17 inch. Overall Height 36 inch. Overall Open Width 23 inch., 25 inch., 27 inch

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

When movement is impaired by injury or a chronic health condition, a transport wheelchair can help regain some of the mobility. The traditional or standard weight transport wheelchair has two large rear wheels and a pair of smaller wheels in the front. Advances in design and materials have made different models available to suit different needs. Lightweight transport wheelchairs made of light but sturdy aluminum are a good choice for more active individuals, as well as for people who take frequent trips from home. when the wheelchair will need to be folded and more easily lifted and stowed in a car trunk. A transport chair solves limited mobility issues without the need to use a traditional wheelchair that is heavy and hard to collapse and put in a car. A transport chair typically has four small wheels, two in the front and two in the rear. Lightweight wheelchairs are effortlessly carried up and down stairs due to their ultra light nature and portability, making them the perfect choice for those who do not require a wheelchair at all times. The chair can be simply folded and stored until required. Travelling by car, coach or plane is made simple and the practicality of a wheelchair that is easily manoeuvred and stored makes everyday life uncomplicated and stress free. Choosing the right wheelchair that meets every personal requirement is an important decision for all wheelchair users. They offer a wealth of benefits as well as a wheelchair that is durable and adaptable, with numerous opportunities to be personalised to meet each individual need. Lightweight transport wheelchair mobility chairs feature adjustable frames, which allow to change the angle of the seat back to achieve several different seating positions. Lightweight wheelchairs with desk-length armrests enable users to sit closer to a table or desk; while, full-length armrests provide complete support of the arms. Karma KM 2500 L Big Wheel Wheelchair: Karma KM 2500 L Wheelchair Specifications:

Walking disabled people are more fortunate nowadays. While in the past they always have felt incapacitated and immobile, nowadays, they are provided with more and better means to roam and move around. With the development and heightened popularity and usage of wheelchairs, such handicapped people are given more advantage and privilege. The emergence of transport wheelchairs have significantly helped improve the way people make use of wheelchairs. Transport wheelchairs are machines or equipment that facilitate for mobility and movement of wheelchair confined people at public places. While it is true that simple wheelchairs can do the trick, transport wheelchairs are specifically designed and manufactured to facilitate better roaming and mobility at malls, restaurants and parks where people usually converge to relax. Transport wheelchairs provide many advantages: Weight: As the name implies, they are easy to transport because they typically weigh around 15 to 20 pounds, which is much less than a manual wheelchair. Storage: They are easier to store than traditional manual and electric wheelchairs. Most are small enough to fit into the trunk of a compact car. Karma Travel Wheelchair KM TV 20.2: Karma Travel Wheelchair KM TV 20.2 - 606 T-6 aircraft-grade aluminum-alloy frame provides incredible strength. Easy-to-fold in three seconds. Karma Travel Wheelchair KM TV 20.2 Features: Type: Travel Wheelchair T-6 aircraft-grade aluminum Secure brake improve safety Padded flip back armrest PU front caster & rear wheel Karma Travel Wheelchair KM TV 20.2 Measurements: Weight: 8.9kg Seat width: 39.5cm Tyre: PU front casters and rear wheels Capacity: 100kg Folded size: (L/W/H): 610mm x 350mm x710mm. Wheelchair provides comfort and mobility in an economical package. It comes standard with padded nylon upholstery and one-piece armrests that offer a cushioned feel with minimal maintenance. Combined with its stylish silver vein frame and matching fr

Transport wheelchairs are machines or equipment that facilitate for mobility and movement of wheelchair confined people at public places. While it is true that simple wheelchairs can do the trick, travel Wheelchair are specifically designed and manufactured to facilitate better roaming and mobility at malls, restaurants and parks where people usually converge to relax. A seat belt and swing-away removable footrests are standard and make it easy to get in and out of this chair. A fold-down back allows for easier storage and transport and padded armrests add additional comfort. The materials with which travel Wheelchair are made are of more superior quality and strength. That is because Travel Wheelchair are made very specifically to facilitate movement at public and outdoor places. Also, travel Wheelchair are made of materials that are highly durable to enable it to carry out its purpose. Thus, it is often that users complain about the limited usefulness and comfort of using the wheelchairs. 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 use of aircraft-grade aluminium alloy and double

Transport wheelchairs are machines or equipment that facilitate for mobility and movement of wheelchair confined people at public places. While it is true that simple wheelchairs can do the trick, travel Wheelchair are specifically designed and manufactured to facilitate better roaming and mobility at malls, restaurants and parks where people usually converge to relax. A seat belt and swing-away removable footrests are standard and make it easy to get in and out of this chair. A fold-down back allows for easier storage and transport and padded armrests add additional comfort. The materials with which travel Wheelchair are made are of more superior quality and strength. That is because Travel Wheelchair are made very specifically to facilitate movement at public and outdoor places. Also, travel Wheelchair are made of materials that are highly durable to enable it to carry out its purpose. Thus, it is often that users complain about the limited usefulness and comfort of using the wheelchairs. Karma Travel Wheelchair KM TV 20.2: Karma Travel Wheelchair KM TV 20.2 - 606 T-6 aircraft-grade aluminum-alloy frame provides incredible strength. Easy-to-fold in three seconds. Karma Travel Wheelchair KM TV 20.2 Features: Type: Travel Wheelchair T-6 aircraft-grade aluminum Secure brake improve safety Padded flip back armrest PU front caster & rear wheel Karma Travel Wheelchair KM TV 20.2 Measurements: Weight: 8.9kg Seat width: 39.5cm Tyre: PU front casters and rear wheels Capacity: 100kg Folded size: (L/W/H): 610mm x 350mm x710mm. Ultra Lightweight Wheelchair: Its compact design and feather light weight makes it suitable for people on the go. Ultra Lightweight Wheelchair Specifications: Frame Style : Foldable Frame Material : Aluminium (Light weight) Rear wheel to wheel width in open position (inches) : 20" Handle to Handle : 16" Seat Width (inches): 13" Rear Wheel Size: 7" Front Wheel Size: 5" Seat to floor height (inches): 19" Seat Dep

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

Overview: Today's health care delivery occurs in a diverse, fast-changing, multidisciplinary health care environment. This often presents challenges to the health care professional that are not easy to navigate. Medical records and their confidentiality have long been the exclusive province of state law, but has now been recognized for some time in the federal HIPAA statutes and federal regulations. Differing and even conflicting sources of requirements at the state level still exist for the retention and disposition of medical records. These sources may vary based upon the specific health care practitioner - whether physicians, dentists, psychologists, or other health care providers, including mental health practitioners. As to the specific, individual health care practitioner, state laws mandate their confidentiality, retention, and even their specific content with regards to patient, clinical records. In addition to these clinical requirements, additional state laws set forth the content and retention of other types of records kept by the professional, such as supervisory agreements with other professionals subordinate to them as well as their own unique record content requirements. With the majority of medical records moving to an electronic format, special rules now exist with regard to the confidentiality, security, retention, and disposition of electronic medical records. This is particularly important as state laws continue to allow for and regulate the provision of telemedicine by various health care practitioners. For example, while psychotherapy and mental health services are ideal treatments to offer over the internet, that is, by simultaneous audio-visual transmission between the doctor and the patient, the risks of breaches of confidentiality also vastly increase. And when the successful doctor-patient relationship is over, how does the health care practitioner providing a mental health service dispose of these electronic records? In addit

Tynor Functional Knee Support is specially designed to support knees which are injured or not working properly due to old age. It stabilizes knees during rotational and anteroposterior forces and cures the ligamentous knee injuries. It provides support to the knees by wrapping around them and thus facilitates their compression. It provides flexibility and easy movement of the knee. It is made of soft, durable fabric which can be stretched in four ways. It mimics the natural knee joint. It can bear the load and shock exerted on it from the external forces leaving the knee totally free from pressure. It contains no buckling or vaso constriction which might hinder comfort. It ensures the proper circulation of blood. It compresses the patellar region and hold it in right position and thus can be used for patellofemoral diseases. It is easy to maintain. Tynor Functional Knee Support Functional knee Support is an anterior opening device, which offers the advantage of controlled compression around the knee and a rigid lateral support and immobilization. It allows normal flexion and free movement of the knee joint. Anterio Open able Easy application Controlled compression. Perfect lateral splinting. Anatomical design. Tynor Functional Knee Support Features Bi axial heavy duty aluminum hinge Mimics the natural knee joint Ensures full weight bearing. Allows free flexion movement Four way stretchable fabric Controlled and comfortable compression No buckling No vaso constriction Enhanced comfort Open patella design Release patellar pressure Hold the patella in position Can be used for Patellofemoral diseases Wrap design with anterior closing Easy application and removal on swollen or asymmetric knees Easy application and removal for weak or geriatric patients. Allows customized compression Offers flexibility in sizing Ergonomic design Anti tourniquet effect - ensures no constriction to blood flow Better grip of the product to the bo

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Chronic lymphocytic leukemia is a cancerous disease in which cancer cells begin to multiply in the lymph cells. CLL is aggressive cancer that invades the lymphatic system and attacks healthy cells of the immune system. It typically affects the lymph nodes and T cells, although it can also affect any other cells in the human body. The combination of chemotherapy is aimed at destroying cancer cells while at the same time allowing the body's immune system to restore the damaged cells. This allows for a more rapid response to the infection and better overall outcomes. As a result of this combination, chemotherapy is often used to treat several types of cancer at one time. It has been very successful in achieving results against most types of cancer. The targeted drugs are given to make the cancer cells unable to multiply and thus stop their growth. Increasing prevalence of leukemia is expected to drive growth of the global chronic lymphocytic leukemia therapeutics market during the forecast period. According to the American Society of Clinical Oncology (ASCO), chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults aged 19 years and above with 37% of cases. According to the same source, around 21,040 new cases and 4,060 deaths are expected to occur in 2020 due to CLL in the U.S. Furthermore, according to the Leukemia & Lymphoma Society (LLC), in 2020, around 60,530 people are expected to be diagnosed with leukemia in the U.S. Such a high prevalence of CLL and leukemia has increased the demand for necessary therapeutics such as chemotherapy. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/chronic-lymphocytic-leukemia.html

Primary biliary cholangitis, also known as primary biliary cirrhosis, is an autoimmune disease of the liver. The auto-immune disorder can have a number of symptoms such as abdominal pain, fever, nausea, vomiting, abdominal bloating, diarrhea, liver tenderness or enlargement, jaundice, and ascites. In most of these symptoms, the patient may be experiencing inflammation at an early stage of the illness, although in some cases, symptoms do not appear until the disease has advanced to a more serious state. A definitive diagnosis can only be made by performing blood tests and ultrasound studies in order to determine the progression of the illness and its effects on the body. At an early stage, most patients who experience mild to moderate symptoms of primary biliary cholangitis exhibit no symptoms, whereas in some cases, symptoms manifest very quickly and rapidly worsen. In both conditions, the majority of affected individuals undergo treatment that is aimed at relieving pain and treating any complications that might occur. High prevalence of primary biliary cholangitis is expected to propel growth of the primary biliary cirrhosis drugs market. For instance, according to the study, 'Epidemiology and clinical course of primary biliary cholangitis in the Asia-Pacific region: a systematic review and meta-analysis', published in Hepatology International in September 2019, the overall prevalence of primary biliary cholangitis was 118.75 cases per million in the Asia Pacific region, with the high, medium and low prevalence being in Japan and China (191.18 cases per million), New Zealand (99.16 cases per million) and South Korea and Australia (39.09 cases per million), respectively. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/high-prevalence-of-primary-biliary.html

Often, at work due to busy schedules, we tend to neglect ourselves and our health. A proper balance between work and health must be maintained for better productivity. Here are some amazing and breathtaking health hacks at work that help you achieve the above-mentioned balance.

Drug delivery means different methods, approaches, technologies, formulations, and systems for transporting a pharmaceutical compound in the body to achieve desired therapeutic effects. There are different types of drug delivery including intravenous injectable, inhalation, or absorption. The injectable drug delivery is considered the most effective route of administration for the effective delivery of drugs to the targeted sites. This enhances the patient's compliance with the drug. This method of drug delivery boosts the drug adsorption from various sites including intravenous, subcutaneous, and intramuscular. Moreover, it increases the bioavailability of the drug at the systematic circulation of the drug at the designated site of action. The challenges of administering an injectable drug to an area are unique and complex. It is common practice to inject a small amount of a drug into the skin of a subject in order to administer a larger dose. However, many complications could occur if too much of a drug is injected at once. Since most of these systems are designed to administer large amounts over a long period of time, multiple injections could cause serious health problems, such as infection and damage to vital organs. The future injectable drug delivery will require the development of new methods for delivering medications, and the creation of new products that provide a safer, more effective environment for the delivery process. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/injectable-drug-delivery-is-getting.html

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 /