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Course "Verification vs. Validation - Product Process Software and QMS" 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 will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

Course "Fundamentals of Statistical Process Control: Implementation and Assurance of SPC" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2-day seminar provides the information you need to use one of the most powerful tools in quality, statistical process control. It will help people in design, quality, and production understand the concepts and effectively implement them. The examples and issues in the seminar come primarily from the medical device industry, but the material is applicable to any production environment. Production process must be controlled to help ensure they are stable. While there are many control methods, the most powerful and often used is statistical process control, SPC. It uses data from the process itself to detect changes - changes that could result from an unstable process. SPC helps determine if a process continues to operate the way it was set up. If not, SPC produces a signal that calls attention to the problem. One very important application is process capability analysis. With a stable process, SPC data can help determine if the process is capable of meeting the product specifications. These are often expressed as process capability indices. Continuous improvement programs can use the information generated by SPC to monitor process variation and identify its causes. These methods can reduce cost, improve product, and enhance customer satisfaction. Why should you attend: Manufacturing companies, especially medical device manufacturers, must control process. Not only is this a regulatory requirement, but is a good business practice. Without a solid understanding of SPC, you put yourself and your company at a disadvantage. On a personal basis, the material in this seminar will help improve your skills; it aligns with the ASQ Body of Knowledge for the Certified Quality Engineer, Green Belt, and Black Belt. These are areas you should master

2-day In-person Seminar Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing Overview: The 2-day seminar explains how to apply statistics to manage risk 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. 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, from a risk management perspective Agenda Day One Lecture 1: Regulatory Requirements Lecture 2: Vocabulary and Concepts Lecture 3: Confidence Intervals (attribute and variables data) Lecture 4: Normality Tests and Normality Transformations Lecture 5: Statistical Process Control (with focus on XbarR charts) Lecture 6: Confidence/Reliability calculations for Proportions Lecture 7: Confidence/Reliability calculations for Normally distributed data (K-tables) Lecture 8: Process Capability Indices calculations(Cp, Cpk, Pp, Ppk) Day Two Lecture 1: Confidence/Reliability calculations using Reliability Plotting (e.g., for non-normal data and/or censored studies) Lecture 2: Confidence/Reliability calculations for MTTF and MTBF (this typically applies only to electronic equipment) Lecture 3: Statistical Significance: t-Tests and related "power" estimations Lecture 4: Statistical Significance: ANOVA calculations Lecture 5: Metrology (Gage R&R, Correlation, Linearity, Bias , and Uncertainty Budgets) Lecture 6: QC Sampling Plans (C=0 and Z1.4 attribute AQL plans, and alternatives to such plans) Lecture 7: Statistically valid statements for use in reports Lecture 8: Summary and Impleme

Single-use medical device reprocessing refers to cleaning, disinfection, testing, sterilization, and remanufacturing of a used medical device to be put in service again. The reuse of single-use medical devices first began in the late 1970s. According to the Centers for Disease Control and Prevention (CDC), around 20 to 30% of the U.S. hospitals reported having reused at least one type of single-use device. The reuse of single-use devices involves ethical, regulatory, legal, medical, and economic issues, which have faced controversy in the last two decades. The reuse of single-use medical devices has increased typically due to the COVID-19 pandemic outbreak. In general, there are two categories of products that can be reused: active and inert. Active products are required for making new products, while inert products are used for making old products stronger, newer, longer-lasting, and more effective. The useful products that are generated are called inert products. These are products that have a certain amount of value because of their function. They are available in different forms like paper, paperboard, metals, plastic, etc. These products can either be reclaimed from the environment, or produced by industries and used for manufacturing purposes. The mobile devices that need to be recycled for single-use medical device reprocessing include diagnostic devices, sterilization equipment, biopsy instruments, blood glucose analyzers, blood pressure monitors, disposable gloves, medical imaging devices, and many more. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/single-use-medical-device-reprocessing.html

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

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

Overview: Many infectious diseases were historically confined to specific geographical regions. However, some now pose global threats due to ease of travel, globalization of trade and commerce and global warming. Government Agencies, non-Profit Organizations, Philanthropic groups and others are also funding vaccination programs for regions where infectious diseases are endemic and to deal with new outbreaks.. Such developments are stimulating research in and the development of improved vaccines, their manufacture and control. Supply Chain complexities and stability issues need to be addressed to cope with transport of vaccines to and their use in climatically hostile regions. Programs to address such challenges need to be implemented, being resourced by appropriately trained and qualified staff from a number of disciplines. Development programs for immuno oncology products also require staffing by similarly skilled professionals. Workers currently engaged in Discovery, Development and Manufacture of conventional medications , or those seeking career-change opportunities can develop an understanding of the concepts, constraints and opportunities associated with Vaccine products by attendance at the Webinar. Engineering professionals involved in facility construction, or repurposing can also benefit as can Regulatory Affairs Professionals or staff at medicines Evaluation Agencies. The subject matter is particularly suited to professionals who are expert in the various disciplines associated with conventional medications ("so-called "small molecules") who wish to expand and develop their skills by involvement in vaccine-related programs including immuno-oncology. Areas Covered in the Session: History of and development of vaccine concepts. undamentals of vaccination Vaccine Types Administration of Vaccines Future Concepts Immuno-Oncology Vaccine Manufacture Who Will Benefit: Regulatory Affair Managers Project Management Personnel QA Managers Scientists Technol

Advanced Therapy Medicinal Products (ATMPs) offer a real and tangible hope for many different chronic illnesses for which there currently are no or limited therapeutic options. The science and technology that support these products are developing rapidly and therefore the products that are on the market today will undoubtedly continue to improve and grow in effectiveness and capability over time. Patients around the world are now beginning to experience the benefits of these improved products. One such product is Stem Cell Therapy, which uses stem cells from healthy cells taken from the patient's own body. High prevalence of Alzheimer's disease is expected to propel growth of the advanced therapy medicinal products market. For instance, According to the data from Alzheimer's Association, around 5.7 million people in the U.S. were suffering from Alzheimer's disease in 2018. Moreover, increasing adoption of gene therapy is also expected to aid in growth of the market. For instance, in March 2020, AVROBIO, Inc., a clinical-stage gene therapy company, announced that a second patient in the AVR-RD-04 Phase 1/2 clinical trial in cystinosis has been enrolled and has completed apheresis. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/high-prevalence-of-alzheimers-disease.html

Biodegradable mulch film is a product that can be produced from a number of available raw materials. The product can also be developed using bioprocesses or by combining two or more organic mulching products. Biodegradable mulches are produced from leftover pulp from the production of paper. Biodegradable mulches are used as crop production feedstock because their use protects the crop production equipment from surface damage. They provide good weed control by preventing weed seeds from germinating and infecting the seedbeds. The weed infestation reduces the need for herbicides and pesticides, the use of which is restricted when there is a weed infestation. The use of mulches prevents soil erosion by reducing the rate at which the soil is washed away. Biodegradable mulches have been in use for approximately forty years in the United States, although their increasing popularity is likely due to the fact that they are highly effective at providing protection against ultraviolet radiation and other environmental pollutants. There are two types of Biodegradable mulch film - the ones made from recycled plastics and thermoplastic materials. The recycled plastic material Biodegradable is able to withstand the effects of weathering. Thermoplastic mulch film on the other hand is made from polyethylene, polypropylene, and nylons. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/use-of-biodegradable-mulch-film-helps.html

Anti-counterfeit packaging solutions such as radio-frequency identification (RFID), forensic techniques, 2D barcodes, holograms, and more are used to protect customers from counterfeit products. Secure packaging plays a key role in preventing the counterfeiting of any product. Anti-counterfeiting packaging provides a secure and safe packaging solution to the product, in order to eliminate infringement and counterfeiting. Stringent laws and regulations enforced by governments are expected to drive growth of the global anti-counterfeit packaging market during the forecast period. The government of many countries has enforced stringent regulations and laws to curb the counterfeiting of products. Furthermore, in September 2020, the International Trademark Association (INTA) announced to step up its efforts to combat counterfeit products with new laws under consideration. Moreover, in December 2019, in the U.S., the SANTA Act (Stopping All Nefarious Toys in America Act) was introduced that set requirements for online marketplaces selling toys to verify seller information and disclose it to consumers. Read more @ https://sachinbhombe.blogspot.com/2021/03/anti-counterfeit-packaging-market.html

Food Safety and Security are two faces of the coin : Food safety and security are two different, but closely related concepts. Although part of the same aspect, they vary in their application and meaning. Both are equally important in ensuring that populations of the world get food that is sufficient and nutritious. Food safety and security are complete without each other. Food safety complements food security, and vice versa. Food safety : Food safety is essentially about the safety of the ingredients that go into food. If food is being sourced from a farm, the food makers have to ensure that the farm has ensured safety standards in producing this food. Food safety is concerned about the amount of chemicals and fertilizers used in production of food. It is also concerned with how much residual pesticide, which could cause harm to humans when the food that is grown using it, is left in the final product, and so on. Food safety is related to and is dependent on factors such as demographics, inputs that go into the cultivation and production of food, availability of water for production of safe food, the use of energy sources in the safe production of food, climate change, etc. Now, food security : Food security, on the other hand, is about more about the food supply chain. When food arrives from the producer to the consumer, it goes through a complex chain that can many times span entire continents. Food may also be sourced and consumed locally. In either case, there is a need to ensure that the points that food travels in and reaches are secure. Ensuring quality throughout : The aim of food security is to ensure that food which travels through many chains and stages should be clean at all these stages. This means that security has to be ensured from rodents and other forms of disturbances at the agricultural fields in which food is produced, then at the granaries in which it is stored, at the routes that it travels, then at the location at which food is pr

Color cosmetics are cosmetic products that aid in improving the overall look of your body. Color cosmetics include the main colorants used for facial, lip care, skin care and oral care, plus the chemicals used for fragrance and other oral care. The color cosmetics market is a multi-billion dollar business and there are a large number of products available that contain colorants or fragrances. Some of the most popular color cosmetics include lipstick, eye shadow, blush, eye glosses, and blushes. Color cosmetics usually include, two types of compounds: the natural colorants used to make the product and the synthetic colorant compounds used to make the product. Natural colorant compounds include, natural pigments from plants, mica from mined ore and titanium dioxide. Significant growth in the e-commerce sector is expected to offer lucrative growth opportunities for players in the global color cosmetics market over the forecast period. 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. Read More @ https://coherentmarketinsights-blog.blogspot.com/2020/11/increasing-expenditure-on-personal-care.html

Get the wide range of Dementia Products in Ireland at Home Care Technologies to care for people living with dementia. They are all simple to set-up and easy to use. There are a range of products available are memory aids, medication reminder, personal tracker phone and many more.

Overview: The connection between the Body, its physiology and particularly biochemistry, have been linked to the mind with particular emphasis upon emotions and stress. This can be easily substantiated in common everyday situations. Anyone who has observed a facial red flush triggered by some sort of embarrassment can attest to the foregoing connection. The emotions and stress play a key role in many if not all diseases and disorders: due to the vastness of the subject, we will focus on the application of the mind/body connection(MBC) to skin. This serves as an introduction to the field of psych dermatology which, although still in its infancy in the USA, is expanding as evidence with regard to the psychological component related to the etiology of skin diseases continues to grow. Concurrently, the field of Alternative techniques IN mind/body treatments continue to grow in leaps and bounds providing effective methods for integration with conventional cosmetic and dermaceutical treatment. This provides a dual complimentary pathway both for prevention and treatment of any/most skin disorders. Expanding on this model, we have already shown how the mind influences the body as per the above example. This general proposition can be extended to include specific skin disorders such as acne rosacea psoriasis eczema and atopic dermatitis to name a few. We will concentrate on Acne for the sake of this discussion. First, focusing on the B component of the BMC model, the primary lesion associated with acne is the formation microcomodones, which are small enough to proceed undetected until larger comodones appear later in the cycle. The latter cycle is initiated by peroxidation of squalene and unsaturated fatty acids present in human sebum. This leads to the foregoing lesions and pro- inflammatory mediators such as cytokines and interleukins followed by an increase of p.acnes on the epithelial cell wall together with increased film formation of the p.acnes is the same area This

Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this. Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an ove

In this report, we analyze the Ammonia Gas Sensors industry from two aspects. One part is about its production and the other part is about its consumption. In terms of its production, we analyze the production, revenue, gross margin of its main manufacturers and the unit price that they offer in different regions from 2012 to 2017. In terms of its consumption, we analyze the consumption volume, consumption value, sale price, import and export in different regions from 2012 to 2017. We also make a prediction of its production and consumption in coming 2017-2022.

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

The global ayurvedic market is categorized on the basis of product, distribution channel, and region. Based on product, the market is categorized into healthcare products, personal care products, skin care, hair care, oral care, and drugs.

Nutricosmetics refers to nutritional supplements that are used to enhance aesthetic appeal. Skin care usually includes the application of creams, lotions and other skin products. Nutricosmetics can be used to make skin look younger and healthier. The ingredients used to make these products usually include vitamins, antioxidants, and other nutrients that the skin needs to function properly. There are other forms that can be used in making the skin look younger. Increasing aesthetic appeal is expected to propel growth of the nutricosmetics market. For instance, according to a 2018 survey by GlobalData, around three quarters of South Korean men undertake a beauty or grooming treatment at least once a week. Moreover, increasing geriatric population is also expected to aid in growth of the market. For instance, according to the U.S. Census Bureau, the U.S. geriatric population is expected to reach 77 million by 2034. Increasing expenditure on personal care products is expected to offer lucrative growth opportunities for players in the nutricosmetics market. For instance, according to the U.S. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/increasing-aesthetic-appeal-and.html

Tissue Transplantation products and services are getting widely used in the healthcare sectors worldwide. The term Tissue Transplant refers to the process of adding new tissues to the body that is broken down and replaced by other organs or tissues. It is a major breakthrough in organ transplantation and is used more frequently. Tissue Transplantation is the practice of harvesting and replacing human organs such as kidneys, liver, heart valves, lungs, and bones with other healthy tissues from other people. Tissue Transplantation has given hope to many patients who have had to have a hip replaced or a kidney removed because of disease or illness. In recent years, there has been an increase in the number of people who are now choosing to donate their organs and tissues to medical research and treatment centers. More people are now aware of the need for organ donations and more people are now looking to give back to society than ever before. The demand for organ and tissue transplantation is increasing every day. Unhealthy food habits lack of exercise, drug abuse, and alcohol consumption results in organ failure, owing to which the demand for the Tissue Transplantation products and services market is estimated to rise. Increasing events of acute diseases are also estimated to aid the growth of the market. For instance, high blood pressure and diabetes are the main causes of end-stage renal diseases where kidney dialysis or transplant are the only options to save the patients. According to the U.S. Department of Health & Human Services, in 2019, there were approximately 122,913 patients in U.S. who needed urgent tissue transplants. Hence the increasing demand for advanced transplantation products is estimated to drive the market growth. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/the-global-tissue-transplantation.html