How to Find the Right “DIETARY SUPPLEMENTS” for Your Specific Product (Service)

These have to match what is specified in the master manufacturing record.

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Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.

Please visit http://bit.ly/2DIk8lf to enroll for this webinar.

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How to find the right dietary supplements for your specific product (service) can be quite a challenge, if you are one of the players in the industry. The reason is this: manufacturers, labelers and packagers of dietary supplements, and even those who hold them, have to comply with the requirements set out in 21 CFR Part 111.

21 CFR Part 111, or what is called the “DS CGMP rule”, requires those who manufacture, package, label and stock dietary supplements to ensure the quality of the product by adhering strictly to the packaging and labeling requirements set out in this Part. These have to match what is specified in the master manufacturing record.

Till the FDA published the Dietary Supplements CGMPs as a “Final Rule”, which brought 21 CFR 111 into existence, the Quality Management Systems and controls on dietary supplements were loose and voluntary in nature. About the only requirement was the one set out by the Dietary Supplement Health and Education Act of 1994 (DSHEA), by which the Congress defined what is meant by a “dietary supplement”, and only required that every supplement be labeled a dietary supplement.

Complying with 21 CFR 111 is not optional

All that has changed with 21 CFR 111. To start with, the FDA now has a set of regulations for dietary supplements that is different from what is set out for conventional foods and drug products.  And then, players in the dietary supplements field that fail to comply with these requirements can have their products termed “adulterated” or “misbranded” by the FDA.

Despite the introduction of this Part, considerable confusion abounds in the industry as to just what type of manufacturing controls and record keeping, and labeling content the FDA requires, with the result that this Part continues to be a regulatory sore point for many new and established companies in the industry.

It is this confusion that this webinar seeks to clarify. John E. Lincoln will help participants of this session resolve these issues.

John will explain all the aspects of FDA Part 111, which will include Quality Management System/Quality Assurance/Quality Controls, personnel, facilities, equipment, software controls, production and Process Controls, holding and distribution, complaints and returns, and records.

At this 90-minute webinar, which is aimed at benefiting Senior Management in the dietary supplements industry, QA/RA, R&D, Consultants, those in Engineering and Marketing, those tasked with Product, Process, Validations and CGMP responsibilities, as well as other interested consumer groups, medical and other healthcare professionals, staff and office personnel, and start-ups, John will cover the following areas:

  • History of Dietary Supplement regulation in the U.S
  • The Dietary Supplement Health and Education Act (DSHEA)
  • The key requirements of the Dietary Supplements CGMPs, 21 CFR 111
  • Required steps for CGMP compliance
  • Problem areas, common pitfalls
  • Implementation: Systems, templates and tools.

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About the speaker:

John E. Lincoln is a graduate of UCLA. His experience also includes managing pilot production, regulatory affairs, product development/design control, 510(K) submissions, risk management per ISO 14971, and projects. He brings over 28 years of experience in the FDA-regulated medical products industry, during which he has worked with companies ranging from startups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt.

How to plan for post radiation resistance and lifetime functionality

Will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

The following subjects will be covered in detail:

  • Materials Guidances – AAMI TIR # 17, ASTM
  • Sterilization validation and Bioburden
  • Shelf Life Test Methods – Accelerated Aging design
  • Product design
  • The influences of product assembly (molding, automation, etc.)’
  • Material selection and post irradiation degradation
  • Regulatory Guidances – AAMI/ISO 11137, TIR #17
  • Packaging Design and Materials

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“Do it right the first time”, choose the most functional and radiation resistant materials for your medical device instead of going through the post launch cycle of product revisions. Also learn the basis for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics. Learn how to “think like a molecule” and plan and design around radiation induced changes in materials qualities (color, odor, brittleness). How to avoid the materials that are “APT” to fail.

Learn how to:

  • Keep color and odor out of your irradiated products
  • Enhance product and packaging designs to take advantage of radiation
  • Medical Product Design Engineers
  • Sterilization Experts
  • Quality Management and Engineers
  • Regulatory Affairs
  • Project Managers
  • Purchasing and Supply Chain Managers
  • Staff Evaluating Risk, Safety, and Effectiveness
  • R&D Staff – Engineering and Lab Personnel
  • Process Engineers
  • Packaging Engineers
  • Materials Engineers
  • Manufacturing Engineers

Identify the materials that perform best upon radiation

Healthcare Supply Chain Reaches Master [Level Ranking]

When we move initiatives forward, we do so with the dedication and commitment to improve value.

Annual Gartner Healthcare Supply Chain Top 25 list recognizes Intermountain Healthcare for initiatives to provide highest quality products and services at the lowest possible cost.

Intermountain Healthcare has reached a “Masters” designation in the annual Gartner Healthcare Supply Chain Top 25 list. The Healthcare Supply Chain Top 25 ranking and designation, recognizes manufacturers, providers, distributors and retailers from across healthcare that demonstrate leadership in improving human life at sustainable costs. After being ranked in the top five over the past seven years, Intermountain is recognized in Gartner’s new Master classification, an additional dimension of achievement. Gartner is a national business consulting company who has issued the ranking the past ten years.

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Intermountain earned the Master level based on sustained supply chain performance over a period of time. Intermountain was ranked #1 on the Gartner list in 2016 and 2017 and #3 the two prior years. Intermountain’s strong bond rating, its supply chain organization’s initiatives to improve value and lower healthcare costs, the health system’s comprehensive approach to serve the patient, and innovative problem solving are among the factors to achieve the newly created title.

“Our supply chain team does an outstanding job to ensure we’re using the highest quality products and services at the lowest possible cost,” said Marc Harrison, MD, president and CEO of Intermountain Healthcare. “This team continually raises the bar in quality and affordability and demonstrates—year upon year—their commitment to making a difference for those we serve. We are honored to be on this prestigious list as a Master.”

John Wright, vice president of Supply Chain and Support Services for Intermountain, adds, “This is a humbling experience to now be ranked as a Master and a designation which I’m very appreciative. Intermountain Supply Chain leaders before me staged us for this honor long ago and I’m proud to have led us the past year to continue our work forward. Recognition of this type validates our passion and conviction within the supply chain to make a difference for our patients. I know that when we move initiatives forward, we do so with the dedication and commitment to improve value.”

 

If You Haven’t Heard Yet, Quality Management Is [Your Best Bet] to Grow

The business may be a century old or it may have started out recently. Quality is thus inherent into the company’s product lifecycle and has to be ensured throughout the existence of the product and the business.

What are the parameters that set organizations on the growth path? Is it the market size? Is it the people? Is it the system or the technology? While all these are crucial components for an organization, the underlying element in all these is Quality Management. Quality Management is that one core ingredient that steers organization through its business and ensures its growth. If you haven’t heard yet, Quality Management is your best bet to grow.

How? Simple: there is no substitute for quality when it comes to the organization’s ability to deliver. Quality is the soul of a business. Quality is at the root of an organization’s performance. Without quality products or services, the organization loses its reputation in the market. A business that loses its name loses everything.

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Cannot assure quality? Be prepared to lose customers

These consequences of not having quality products or services are understandable because when customers feel that their quality expectations are not being met, they switch over their loyalties at the snap of a finger. This departure of the customer base can happen at any time. The business may be a century old or it may have started out recently. Quality is thus inherent into the company’s product lifecycle and has to be ensured throughout the existence of the product and the business.

This process of building a business into which quality inheres and is present throughout the lifecycle is symbolized by the concept of Total Quality Management or TQM. TQM is an approach whose concepts help organizations reach their quality goals by taking their unique business and product-related aspects into consideration. It is a system in which the concepts can be applied during all phases, as well as all situations of the business: in times of prosperity, in times of stability, in times of flux, as well as in times of adversity.

Overall improvement into the process

TQM suggests an organized and logical manner in which to apply concepts and principles of quality to bring about improvements in the product or service. TQM is about developing a system in which all the processes come into play in an organized and harmonious manner. It is all about making the systems as foolproof as one can. If a fault is present, it has to be so in the system and not in the line employee. In other words, TQM is all about putting in place a process-oriented, rather than a people-oriented Quality System.

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Total Quality Management is comprehensive from another perspective: in involving the employees of the organization. Applying TQM is not limited to the top brass of the organization. This principle requires the involvement and participation down to the last level of employees.

Also, for quality to come about, the active involvement of not only the employees, but also those involved in the organization externally, such as consultants and contractors, is as crucial.

The customer at the core

The concept of Quality Management is built placing the customer at the center of the policy implementation. The concept of TQM is built around the belief and fact that the customer is the heart of a business. This is natural, because if there is no customer, there is no business. A customer can exist without a business, but can a business exist without a customer? No.

By placing the highest and maximum emphasis on the customer, Quality Management works around this core component of the business. Quality is not a standalone parameter. It is always achieved and measured in terms of what the customer thinks about it. Quality is of no consequence unless the customer thinks and feels that her quality requirements and expectations have been met. Quality is something that can only be assessed in relation to this core.

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Benefits of implementing Quality Management

The concept of Total Quality Management is built in a manner that makes it all encompassing in its sweep. From both the perspectives of the what each employee is expected to do, to what areas of quality the organization can bring about by modifying their behaviors and attitudes, TQM is an all-round tool. By instilling these aspects into the product or service, organizations are put on the growth path with utmost certainty. Having a Quality Management plan in place ensures the following:

  • There is drastic, micro level improvement in the overall functions of the organization
  • It ensures that the quality expectations of the customers are not only met, but at times, exceeded as well, since the customer is the focal point of a TQM system
  • Implementation of TQM into the lifecycle of the organization’s product or service brings costs down since it is aimed at reducing the errors
  • This brings about a palpable rise in the organization’s name in the market.

All these point to the clear and unmistakable role of quality to organizations. If you haven’t heard yet, Quality Management is your best bet to grow.

https://psychology.iresearchnet.com/industrial-organizational-psychology/organizational-development/total-quality-management/

http://pubs.sciepub.com/ajie/1/3/2/

https://www.researchgate.net/publication/267271713_Total_Quality_Management_as_a_Paradigm_of_Business_Success

https://www.strategy-business.com/article/16188?gko=52d0b

The FDA steps up efforts at bringing about medical device cyber security

This FDA guideline seeks to enforce medical device cyber security by ensuring that the manufacturers take steps to secure medical devices by clearly defining medical device cyber security.

It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cyber security is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built into them.

An important factor that makes medical devices vulnerable to cyberattacks, thus triggering and hastening the need for medical device cyber security is that many times, medical devices are not standalone devices. They are connected via the Net to a number of important sources such as hospitals, electronic records and healthcare providers.

This fact makes it easier for hackers to carry out cyberattacks on medical devices because it is not necessary for them to actually have access to the device to carry out their breach. All these factors combine to make medical device cyber security a much needed system.

The FDA guideline of June

Keeping in mind the nature of fallibilities in a medical device; the FDA, with the intention of bringing about medical device cyber security passed the draft guideline on this topic in mid-2013. Titled the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; this guideline sought to address the issue of medical device cyber security by making an attempt at identifying the issue from its root.

That is, this guideline on medical device cyber security put in place security checks and procedures that manufacturers of medical device have to put in place right from the earliest stages of manufacture, going all the way up to the time it is implanted in or used by the patient.

The main intention of this FDA medical device cyber security guideline is to offer recommendations that medical device manufacturers need to take to reduce the intentional or unintentional risk of an attack on a medical device. This FDA guideline seeks to enforce medical device cyber security by ensuring that the manufacturers take steps to secure medical devices by clearly defining medical device cyber security.

Terms clearly defined

The FDA defines medical device cyber security as steps taken to prevent any of these:

  • Unauthorized modification
  • Misuse of the device
  • Denying the use of the device
  • Unauthorized use of the information that is stored in these devices. This relates to the information stored, accessed and modified when the device is transferred from one source to another

Documentation is at the heart of ensuring medical device cyber security

Towards ensuring medical device cyber security as defined by it; this FDA guideline requires manufacturers to monitor and document all the aspects of medical device cyber security at all stages. Medical device manufacturers should bring about medical device cyber security by developing a set of controls in three vital areas:

  • Firstly, medical device manufacturers should take steps to permit only authorized personnel into the software of the medical device
  • Medical device manufacturers should also ensure medical device cyber security by filling only relevant and accurate data into the device
  • They should also ensure that data is available when asked for

For more interesting https://goo.gl/ZrJ6sv

Cold chain challenge is key to making vaccines ubiquitous

A power outage can break this cold chain and result in the vaccine losing its effectiveness.

Over the years vaccines have prevented countless cases of disease and saved millions of lives. Infectious diseases like polio, measles, diphtheria, pertussis (whooping cough), rubella (German measles), smallpox, mumps, tetanus and rotavirus used to be common around the world. Today vaccines can prevent them.

Despite this, one in five children in the world aren’t fully protected by even the most basic vaccines. In addition, almost 20 million are at risk of contracting preventable diseases because they are under-vaccinated. As a result about 1.5 million children die every year from diseases that can be prevented by vaccination coverage.

One of the main reasons is that there are many rural areas in the world that don’t have reliable power supplies. Vaccines need to be kept at particular temperatures, usually refrigerated, to remain effective. Cold chain conditions aren’t possible without power. A cold chain is a temperature-controlled supply chain that runs from the time the vaccine is produced until it’s administered. It holds the vaccines in a temperature of between 2°C and 8°C. A power outage can break this cold chain and result in the vaccine losing its effectiveness.

Vaccines-for-Life

The Global Alliance for Vaccines and Immunization estimates that only 10% of health care facilities in the world’s poorest countries have a reliable electricity supply. In Uganda, for example, over 70% of health care facilities have inadequate access to mains power.

The World Health Organisation estimates that more than 50% of vaccines may be wasted globally every year because of temperature control, logistics and shipment-related issues.

Most government guidelines recommend that vaccines that have potentially been compromised should be discarded. This can be costly. In 2011, according to UNICEF, an estimated USD$ 1.5 million worth of vaccines were lost in five months, often due to difficulties maintaining cold chain vaccine supply to their remote location.

The WHO has developed a set of guidelines for governments in a bid to minimise exposure to high temperatures if a power outage happens. But our research shows that these guidelines don’t have any specific instructions on how health care facilities and pharmacies should implement backup systems. They also don’t provide a list of standardised equipment to prevent and deal with power outages. This would be helpful in both developed and developing country scenarios. Our research attempts to plug this gap.

Read more at http://bit.ly/2NR2C0q

Facts About Compliance Courses

What is compliance? We all know the commonly used meaning of the term. One of the meanings The Oxford Online Dictionary has for compliance is its being “(t) he state or fact of according with or meeting rules or standards”. So, in the context of the regulated industries, compliance is being in a state of acquiescence or agreement with the regulatory requirements. The rules or requirements are set out by the regulatory authorities such as the US FDA or the European Union’s European Medicines Agency (EMA), or The Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK, or The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, or any other around the world.

The regulations these regulatory agencies set are aimed at ensuring compliance with standards. Of course, it goes without saying that these standards are aimed at ensuring quality and safety of drugs and other health-related products such as medical devices, food, medicines, life sciences and pharmaceutical products. It is to be in compliance with the regulations set out by these agencies that organizations that come under these regulatory bodies spend a fortune.

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Why? Simple:

– Being in compliance ensures that their products are approved for release into the market, failing which all that they spend on producing the product goes down the drain;

– Lack of compliance results not only in hefty penalties and fines and other punishments which could go all the way to imprisonment; it could also result in earning a bad reputation, the quickest means to get out of business.

Compliance requirements, expectedly, are very stringent. This is very natural, considering the nature of the products that are regulated. No regulatory agency likes to take chances with the health of the people. One spurious drug in a lot of thousands could be enough to cause damage to the consumer. So, regulating these products is as onerous as ensuring the security of every individual in a nation or society.

Compliance requirements are couched in very formal and often incomprehensible language. Since the industries are highly specialized, it is impossible for the regulatory agencies to avoid jargon or legalese. It is to help understand the nuances of these regulations that organizations need the services of compliance professionals. These professionals are specialized in the particular and exact nature of these regulations and do what is required to ensure compliance.

Despite the existence of these compliance officers, many organizations could still need understanding of the regulations. This could sometimes be because of the frequency of the regulatory updates or the urgency in meeting their requirements. Or, these could be beyond the resources the organization can allocate or afford for meeting compliance requirements. Further, the nature of some regulations could be such that even experienced compliance officers may need clarity. On such occasions, organizations need the services of compliance trainings.

Continues here http://bit.ly/2vhqsuC