Introducing the NEW Z Wave Q from Zimmer MedizinSystems


Introducing the NEW Z Wave Q from Zimmer MedizinSystems - A New (and Quieter) Dimension in Radial Pulse Technology

Introducing the NEW Z Wave Q from Zimmer MedizinSystems – A New (and Quieter) Dimension in Radial Pulse Technology

Practitioners have been aware, and studies have shown for years, the benefits of Z Wave’s acoustic sound therapy… The appeal of the Z Wave Q over the Z Wave Pro generation, is the device’s quieter operation. After all, the ‘Q’ in the device’s name is for ‘Quiet’.

Zimmer MedizinSystems announces the launch of the new Z Wave Q, the next generation, reengineered acoustic shockwave device that revolutionizes Radial Pulse Technology.

The company’s progressive Z Wave Q device makes its debut on the medical aesthetics market. Like the rest of the Z Wave family of non-invasive devices, the Z Wave Q is FDA cleared for the temporary reduction of the appearance of cellulite, the temporary increase in local blood circulation and to relieve minor muscle aches and pains. Z Wave Q may also be used as an adjunct in Cryolipolysis™ (CoolSculpting™) and other body contouring treatments for enhanced results. Unlike any similar devices, the Z Wave Q utilizes a new type of water-cooled generator. This enables the device to operate with a 50% softer sound than its predecessor, the acclaimed Z Wave Pro, while providing equally effective results. In fact, Zimmer touts the Z Wave Q as the “quietest shockwave device on the market”.

Michael Busic, Director of Zimmer USA’s Z Wave Division, explained the reason for Z Wave Q’s muted sound and uniquely effective treatment capabilities. “Z Wave Q is the only ESWT system with water cooling,” he said. “This brings several benefits. Most notably, a significantly quieter, more pleasant experience for the patient, the operator, and the facility. The water cooling also brings convenience to the practitioner with its ability to perform longer procedures with a single hand piece. Our water-cooled hand pieces will not overheat. You do not have to alternate hand pieces during longer procedures or throughout the day.”

Busic stressed that the device retains the original Z Wave’s comfortable treatment sensation. “Zimmer has always used electromagnetic technology, unlike most other shockwave devices on the market, which use pneumatic technology. Sir Isaac Newton’s Second Law of Motion states that F=ma. Our electromagnetic technology uses a projectile that has a 5 times greater mass than pneumatic (or compressed air) technology. This makes for equal Force using 5 times less acceleration. Less acceleration means a softer, more comfortable pulse on the surface of the patient’s skin. That is what is behind Zimmer’s ‘Soft Shot Technology’. Some who have experienced competitive devices have sensed that Zimmer’s devices are more comfortable for the patient. For procedures that have commonly required topical anesthesia with other devices, Zimmer users are finding that it is not necessary. Our Soft Shot Technology is the reason for that.”

Interest in the new device has been strong, Busic disclosed. His team has been fielding inquiry calls not only from new customers, but also from existing Z Wave users. The reason is simple, he says, that so many doctor’s offices and medspas are showing interest in the upgrade. While practitioners have always enjoyed the device’s effectiveness, the quieter ambient sound of the Z Wave Q is more suitable for the aesthetic environment. Busic commented, “Practitioners have been aware, and studies have shown for years, the benefits of Z Wave’s acoustic sound therapy… The appeal of the Z Wave Q over the Z Wave Pro generation, is the device’s quieter operation. After all, the ‘Q’ in the device’s name is for ‘Quiet’.”

You may watch Busic’s short video introduction to the Z Wave Q here.

About Zimmer Z Wave Q

Radial Pulse Technology was never this quiet – and felt this good! The new Z Wave Q system is equipped with an innovative water-cooled generator ensuring high efficiency and durability. The new ergonomic hand piece with “shock absorber” offers the industry’s quietest operation, the highest level of safety, and maximum comfort to the patient. The Zimmer Z Wave Q transmits powerful sound waves into tissues. The energy then spreads out radially to enhance the treatment effect (Radial Pulse Therapy). The body responds to these sound waves with enhanced metabolic activity in the form of lymphatic drainage and increased blood flow. The result is an improvement in the appearance of cellulite and for other body contouring procedures, improved results with an easier recovery. For more information about the Z Wave Q, you may visit a web overview of the product. You may also contact Zimmer MedizinSystems any time by phone or email.

About Zimmer MedizinSystems

Zimmer MedizinSystems in Irvine, California, with its parent company based in Neu-Ulm, Germany, has 50 years of expertise in manufacturing high quality medical devices. Originating as a manufacturer of physiotherapy devices, Zimmer rapidly evolved as a global leader in the aesthetic industry. The company is represented in over 110 countries worldwide by local distributors who provide exemplary service.

Zimmer’s Aesthetic Division manufactures award-winning devices for the treatment of cellulite and enhancing body contouring, as well as skin cooling during laser and other dermatological treatments. Zimmer’s Z Wave and Z Cryo, devices utilize advanced Radial Pulse Therapy and Cryotherapy technologies. With over 45,000 Cryo units sold, the company has set the gold standard for Cryotherapy and skin cooling systems and has significantly contributed to safer laser treatments while improving patient comfort.

For more information on these and other products offered in the USA, please visit the company’s website at http://www.ZimmerUSA.com, call 800-327-3576 or email info@ZimmerUSA.com

Media Contact:

Regina West

Zimmer MedizinSystems

3 Goodyear, Suite B

Irvine, CA 92618

Corp: 800-327-3576

http://www.zimmerusa.com

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Cutting Edge Spine Announces FDA 510(K) Clearance of its EVOL-SI Joint Fusion System; Bringing Novel Super Hydrophilic Nano-technology to the Sacral-iliac Fixation Market


EVOL-SI Joint Fusion System

EVOL-SI Joint Fusion System

Once again, Cutting Edge Spine has demonstrated its ability to lead the development and commercialization of bioactive spinal solutions that improve patient care.

Cutting Edge Spine, a leader in the organic development and commercialization of bioactive technologies for the spine, today announced the 510(K) clearance of its novel SI joint fusion system, the EVOL-SI.

The EVOL-SI features a unique surface modification that is proven to improve osseointegration through superior hydrophilicity and optimized surface chemistry, as demonstrated in over 20 in vitro and in vivo studies. This combination, with optimized nano-roughness, mediates bioactivity and influences tissue regeneration that yields early bone formation, improving mechanical stability, while promoting faster fusion and stronger fixation.

“Once again, Cutting Edge Spine has demonstrated its ability to lead the development and commercialization of bioactive spinal solutions that improve patient care,” said Randy Roof, President, CEO & Founder. “Raising the bar in patient care is our core objective, and the EVOL-SI system fully supports this objective; providing a solution that potentially eliminates unfavorable issues historically associated with devices utilized in lateral SI joint fusion procedures.”

Cutting Edge Spine is currently in the process of launching the EVOL-SI technology. The company will be exhibiting at the North American Spine Society Annual Meeting in Chicago, IL September 25-28, Booth #2005. Please visit the booth or contact info@cuttingedgespine.com for more information about the EVOL-SI technology and Cutting Edge Spine.

About Cutting Edge Spine

Established in 2009, Cutting Edge Spine is a proven leader in organic development and commercialization of novel bioactive spinal implant systems focused on improving patient care while offering patients, payors, and providers an optimal fiscal value proposition.

Cutting Edge Spine, LLC

101 Waxhaw Professional Park Drive, Suite A

Waxhaw, NC 28173

R.Roof@cuttingedgespine.com

(704) 243-0892

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Cprime Acquires ASPE to Expand Customer Training Capabilities and Accelerate Agile Transformations


This acquisition will allow us to offer new innovative training solutions […] It is an important investment that we make in furthering our ability to help worldwide customers be more effective, efficient, and ultimately successful in their transformation journey. -Zubin Irani, CEO at Cprime.

Cprime, one of the top Agile, Atlassian and Cloud global consulting companies and one of the largest providers of both public and private Agile training in the United States, today announced it has acquired the American Society of Professional Education (ASPE), a leading IT professional development company based in North Carolina.

ASPE specializes in building custom learning solutions that provide organizations the tools and knowledge necessary to make them more efficient, effective, and successful. Through their wide range of Subject Matter Experts, strategic partnerships and their unique teaching methodology, ASPE disrupts the traditional models of learning by introducing innovations in classrooms, virtual-led classrooms, hybrid learning environments, eLearning, and MOOC environments.

The acquisition will combine ASPE’s strong and diverse catalog training capabilities with Cprime’s thriving Agile Training University, and will enable Cprime to expand its current training offering into new technical / business domains and continue to address customers’ growing needs, from IT professionals to end users.

Kreisler Ng, Head of Training at Cprime, explains: “ASPE augments our current knowledge offerings and allows us to deliver flexible and progressive training programs to support customers nationally and globally. Through this acquisition, we will be able to offer all our customers a more comprehensive, world class-solution.”

Bringing ASPE into its fold will further Cprime’s ability to support customers in their agile transformations. With the help of Cprime’s Agile coaches, organizations can construct their own tailored training curriculum to meets their objectives and helps prepare them for the challenges and opportunities of the marketplace.

“Teaming up with Cprime expands our reach and allows us to continue and apply our unique approach to assist organizations increase the overall efficiency, skill level and productivity of their workforce,” said Amanda Alderman, President of ASPE.

The acquisition will enable customers to accelerate the adoption and consumption of new technologies by providing effective and tailored training solutions in areas such as DevOps, IT Ops, project delivery, management and business performance.

“ASPE is recognized for their unique training methodology and the effective results they’ve demonstrated in the area of IT and professional development,” said Cprime CEO, Zubin Irani. “Training is a cornerstone of Cprime’s operating model. This acquisition will allow us to offer new innovative training solutions, including a larger schedule with additional training options such as virtual, in-person, and online. It is an important investment that we make in furthering our ability to help worldwide customers be more effective, efficient and ultimately successful in their transformational journey.”

About Cprime

An Alten Company, Cprime is a global consulting firm helping transforming businesses get in sync. Cprime is the partner of choice for Fortune 100 companies looking to achieve value and agility. We help visionary business leaders compose solutions, execute implementations, and exceed against business goals. With our key partnership recognitions, including Atlassian Platinum, AWS Advanced, and SAFe Gold SPCT partner, our industry-leading software and services work in synergy to deliver transformations. Follow Cprime on Twitter at @CprimeInc.

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Introducing NanLite MixPanel RGBWW LED Panels


https://www.prweb.com/

Nanlite

“Nanlite is incredibly committed to helping creative professionals at every level be more creative, differentiate themselves from their peers and become more successful. The new MixPanels deliver an unprecedented range of features allowing for all sorts of exciting possibilities.”

NanGuang and MAC Group are proud to introduce The Nanlite MixPanel Series, comprised of two LED light panels which uniquely combine three LED light sources into one compact housing, and allows videographers, filmmakers and content creators the ability to switch between hard light, soft light, and colored light at the touch of a button. Coupled with ultra-bright light output, 0-100% dimming, a CRI of 98, a TLCI of 95, green/magenta adjustment, 43 gel presets in two light sources (3200K & 5600K), and 9 special effects; the MixPanels are designed to be some of the most versatile RGBWW LED panels on the market.

Three LED Light Sources in One Compact Panel

NanLite MixPanels are capable of switching between a “traditional” multi-LED panel for hard light, a diffuse SMD LED panel for soft light and a tuneable RGB panel for colorful, creative effects at the push of a button. Now, whether the project calls for hard lighting with more throw, diffused lighting for flattering portraits and up-close work, or colored light to set moods and express emotions, creators can do it all in one unit with no additional accessories.

Ultra-Bright Output

When using the hard light fixture in normal mode, the MixPanel 60 emits 4,980 Lux@1m 5600K while the 150 emits 11,320 Lux@1m 5600K. When shifted into boost mode, the output climbs even higher to 6,600 Lux at 1m on the 60 and 14,950 Lux at 1m on the 150. Plus, with dimming from 100% down to 1%, the MixPanel 60 quickly adapts to any scene without adding ND filters or diffusion.

Color Perfection

The brightness of a light is important, but without color accuracy, a ton of time and money will be lost in post-production. Both MixPanels feature a CRI of 98, a TLCI of 95 plus Green/Magenta adjustment in CCT mode, allowing creators to shoot with confidence knowing the color reproduction will be precise.

Intuitive User Interface

If there is one thing an RGBWW LED panel cannot be, it’s cumbersome to use on set. The MixPanel’s operating system has been developed from the ground up to be efficient and intuitive to use. The ability to save settings as presets makes your lighting consistent and repeatable.

Gel Emulation and Practical Effects

The MixPanel’s gel emulation mode provides a selection of 43 gel presets in two light sources (3200K & 5600K) encompassing 5x CTOx, 5x CTB, and 33x Calcolor. 9 pre-programmed and adjustable special effects make it possible to imitate lighting scenarios that can otherwise be tricky to recreate such as hue loop, CCT loop, flash, pulse, storm, siren, TV, paparazzi, and candle/fire.

Power Anywhere

Optimized for use in the studio or on location, MixPanels can run off either the included AC adapter or 14.8V (MixPanel 60) or 26w (MixPanel 150) V-Mount batteries (Not Included), so you can operate in any location regardless of power availability.

MixPanel 60 Quick Specs:

  • Size L/W/H: 17 x 3 x 14 in
  • Weight: 7.3 lbs
  • Color Temp: 2700-7500K
  • CRI: 98
  • TLCI: 95
  • Dimming: 0-100%
  • Lumen Output 7500K: 5808 Lumen
  • Lux @ 1m 5600K Boost & Soft Light Mode: 935 lux
  • Lux @ 1m 5600K Boost & Hard Light Mode: 6600 lux
  • Lux @ 1m 3200K Boost & Soft Light Mode: 892 lux
  • Lux @ 1m 3200K Boost & Hard Light Mode: 6015 lux
  • Power Source: DC15V/6A
  • Max Power Draw: 60w
  • Battery: Sony V-Mount 14.8v Battery(Not Included)
  • Battery Run Time at 100% Brightness (approx): 2 Hours (14.8v Sony V-Mount 150wh)
  • Mount: 5/8″” Receiver
  • Gel Emulation:43 gel presets in two light sources (3200K & 5600K) encompassing 5x CTOx 5x CTB, and 33x Calcolor
  • Special Effects: hue loop, CCT loop, flash, pulse, storm, siren, TV screen, paparazzi, and candle/fire.
  • Green/Magenta Adjustment: Yes in CCT Mode

Learn More

MixPanel 150 Quick Specs:

  • Size L/W/H: 19 x 3 x 16 in                                                
  • Color Temp: 2700-7500K                                                
  • TLCI: 95        
  • Weight: 9 lbs
  • CRI: 98
  • Dimming: 0-100%
  • Max Power Draw: 150w
  • Mount: 5/8″ Receiver                                                                
  • Lumen Output 7500K: 12144 Lumen                            
  • Lux @ 1m 5600K Boost & Soft Light Mode: 2200 lux
  • Lux @ 1m 5600K Boost & Hard Light Mode: 14950 lux    
  • Lux @ 1m 3200K Boost & Soft Light Mode: 1941 lux
  • Lux @ 1m 3200K Boost & Hard Light Mode: 15040 lux
  • Power Source: DC24V/7.5A
  • Battery: Sony V-Mount 26v Battery(Not Included)
  • Battery Run Time at 100% Brightness (approx): 1.3hours (26v Sony V-Mount 230wh)
  • Gel Emulation:43 gel presets in two light sources (3200K & 5600K) encompassing 5x CTOx 5x CTB, and 33x Calcolor
  • Special Effects: hue loop, CCT loop, flash, pulse, storm, siren, TV screen, paparazzi, and candle/fire.
  • Green/Magenta Adjustment: Yes in CCT Mode

Learn more

“Nanlite is incredibly committed to helping creative professionals at every level be more creative, differentiate themselves from their peers and become more successful. The new MixPanels deliver an unprecedented range of features allowing for all sorts of exciting possibilities.” – Jeff Lazell, Nanlite Brand Manager

For more information contact Nanlite Brand Manager Jeff Lazell: jeffl(at)macgroupus(dot)com

About Nanlite

We make a broad, versatile range of LED lights and accessories designed to help all sorts of image-makers achieve their vision. We are fanatically obsessed with product details, user experience, and quality control. We are equally obsessed with really listening and reacting to our customers; their needs and wishes. Because, for all of us at Nanlite, nothing is more important than helping you be brilliant

Learn more at http://www.nanliteus.com

About MAC Group

32 years ago, MAC Group started as a boutique marketing, sales and distribution group focusing on professional photographers. As the industry has evolved, so has MAC Group with their expansion into filmmaking, video, mobile, content creation and audio. Today, MAC Group is one of the leading companies of their kind with world-renowned brands offering products and education that enhances the lives of passionate content creators at every experience level.

Learn more at macgroupus.com

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The Beauty of Setria® – Surge in Wellness-Infused Beauty Creates New Space for Leading Ingredient Supplement Brand Setria® Glutathione


News Image

Wrapping up a week dedicated to emerging Indie beauty trends, International Beauty Expert Corinne Morley spoke at a press luncheon at The Press Lounge in New York City, covering the booming interest in wellness-infused beauty that has taken off industry-wide.

Morley, who has extensive experience in the beauty industry, including holding impressive roles at Estée Lauder and Trilogy Natural Skincare, spoke to the modern meaning of ‘beauty from within’ – noting that while this is not a new concept, consumers and retailers alike, including Sephora, Nordstrom and Anthropologie, are beginning to blur the lines between health supplements and traditional beauty products on shelves.

“Beauty is much more than skin-deep, it’s a reflection of how we’re feeling,” explains Morley, “Everything that we do externally and internally affects the outward appearance of our skin. It’s not just about how we treat the outer surface of our skin, it’s also a reflection of what’s going on inside – from lack of sleep, to stress, from diet, to too much sun exposure, from environmental toxins to what skincare products we choose to use, everything has an impact.”

Morley notes that one of the skin’s biggest enemies is “the environment that we live in,” informing the key beauty media and influencers in attendance that “without a doubt” free radicals, found in our everyday environment, are “one of the most negative influences on how our skin looks and behaves.”

Free radicals are unstable molecules that cause damage to DNA in cells, disrupting normal cell function, while also having the power to deteriorate the skin’s structural support by decreasing its suppleness and elasticity. While free radicals are in our environment every day and are part of the natural aging process, Morley explains that “certain things actually stimulate free radical activity, such as air pollution, UV radiation, smoking, alcohol and poor nutrition, so we want to calm the free radical activity…because we know how damaging [it] can be to our health, wellness, and how our skin is going to age.”

“Luckily,” continues Morley, “there is an antidote – antioxidants. Antioxidants are powerfully combative toward free radicals, because they help neutralize them.”

Glutathione, known as the body’s ‘master antioxidant,’ is found, to varying degrees, in all cells, tissues, body fluids and organ systems in the body. Glutathione can neutralize potentially harmful free radicals, eliminate toxins, chemicals and potential carcinogens absorbed in the body, and can reactivate other antioxidants that are important for skin, hair and nail health like Vitamin E. However, glutathione levels may decrease due to various factors such as age, diet, UV exposure, health conditions, weight, medications, and poor lifestyle habits. Supplementing with glutathione and incorporating glutathione-rich foods into your diet may help raise glutathione levels in the body*. Setria® Glutathione, a patented form of Glutathione, is a branded ingredient that has been clinically researched to help increase the body’s stores of glutathione, and can help support immunity, detoxification, and skin brightening*.

‘Wellness and beauty go hand-in-hand, and research is the cornerstone of both,” states Morley, “Setria® Glutathione is great because now, customers are really demanding quality, research-backed ingredients. This ingredient, found in many supplement products for beauty, detox and recovery, such as BeautifulAlly by Bluebonnet, Genius Beauty by The Genius Brand, Balance by Alaninu, Bright-Eyed Mornings by Zaca, and Setria L-Glutathione Reduced by Healthy Origins, is actually research backed. It’s a pure glutathione, it’s allergy-free, and is suited for everyone to be taking on a regular basis. It’s processed through a fermentation process, which means it doesn’t have any added chemicals – it’s a more natural process.”

As interest in wellness-infused beauty continues to thrive amongst the beauty industry, Kyowa Hakko, manufacturers of Setria® Glutathione, are thrilled to be at the forefront of conversations.

Media interested in setting up an interview with a representative from Kyowa Hakko, or Corinne Morley, to discuss the health and beauty benefits of glutathione, please contact Sara White: sara@adinnyc.com, 212-693-2150.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

About Setria® Glutathione

Setria® Glutathione, manufactured by KYOWA HAKKO BIO CO., LTD., is a clinically studied and patented form of glutathione that, when taken orally, has been shown to replenish the body’s reserves, which may be depleted as a result of poor lifestyle choices, stress or natural aging. Called the “master antioxidant,” glutathione helps protect cells in the body from the damaging effects of oxidative stress and toxins. Setria® Glutathione is manufactured through an innovative fermentation process to yield high purity and high quality, is vegetarian and allergen-free. For more information about Setria® Glutathione, visit http://www.SetriaGlutathione.com.

About Kyowa Hakko USA

Kyowa Hakko USA is the North & South American office for Kyowa Hakko Bio Co. Ltd., an international health ingredients manufacturer and world leader in the development, manufacturing, and marketing of pharmaceuticals, nutraceuticals and food products. For more information visit Kyowa-USA.com.

**Setria® is a registered trademark of KYOWA HAKKO BIO CO. LTD

Equipment Financing Company Crest Capital Celebrates Their 30th Anniversary


crest-capital-is-30-years-old

Crest Capital is 30-Years Old!

We started out being the fastest and easiest to work with, and we’ve stayed that way.

Typically, age 30 represents a significant milestone, as it often marks the true cross into maturity. This is true for people, and it’s true for businesses as well. And in September of 2019, equipment financing specialist Crest Capital celebrates 30 years in business.

“When we started the company back in 1989, the initial goal was making it 30 months. That’s two and a half years, which figured to be a real milestone,” stated Crest Capital founder and President Mark French. “So to not only reach thirty years, but to do so with the momentum and track record we’ve built up is almost surreal. But ‘real’ it is, and we couldn’t be prouder,” he added.

When Crest Capital began, they built their equipment financing service around speed and ease, and without extensive paperwork or excessive restrictions, such as blanket liens or minimum bank balances. And those fundamental values proved very popular with the small business community they serve, and remain very attractive today. They also really matter to Crest’s vendor partners, who rely on Crest to provide easy, fast financing for their own products.

“We started out being the fastest and easiest to work with, and we’ve stayed that way,” said Crest Capital representative Chris Fletcher. “In the early years, it meant phone, fax, and courier. And while those are still used today, we’ve invested heavily in having the best technology available. Many clients can be approved and funded in a few clicks. We’ve also expanded this technology to our manufacturer, distributor, and reseller partners, so they can offer easy, branded financing right on their websites – everyone really likes that,” he added.

French echoed the technology sentiment, but also made sure to note that Crest still has a marked “person to person” way of doing business as well. “Over the years, the internet has certainly made everything more efficient, both for our clients and our vendor partners. But we also mix that technology with a dose of old-fashioned personal service. We still answer our own phones, we call our clients to say hello, and if they have questions, we work with them to make sure they get the right loan structure for their needs. And the number of happy clients and repeat business we get tells us we’re doing something right. Can we do another 30 years? I don’t see why not!” said a smiling French.

About Crest Capital

Since 1989, Crest Capital has provided small and medium-sized businesses with quick, no-hassle financing for business equipment, vehicles, and software, and is also a trusted credit partner for equipment sellers. To learn more about them, call (800) 245-1213 or visit https://www.CrestCapital.com.

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Optimizing Your Compliance Joint IT/QA Programs Webinar, Sept. 27, 2019


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WCG_FDANews_Logo.jpg

Using IT to Improve Data Integrity

Optimizing Your Compliance Joint IT/QA Programs

**An FDAnews/CenterWatch Webinar**

Friday, Sept. 27, 2019, 11:00 a.m. – 12:30 p.m. EDT

https://www.fdanews.com/itdataintegrity

Who should be a key member of the data integrity team?

The IT department.

Don’t let IT become an afterthought in the data integrity effort. With the increase in digitized records one of the key team members is IT.

The success of the next inspection could depend on the technological component of data integrity. So here’s what to do …

Mark the calendar for Friday, Sept. 27, when data management guru Israel Heskiel shows attendees how to close the gap between IT and the rest of the team. Mr. Heskiel boasts more than 20 years of IT leadership. Over 90 fast-paced minutes, attendees will learn the path to compliance with FDA Data Integrity Title 21 Part 11 in the organization. Prepare to discover:

  • Communicating with IT leaders about IT’s role in data integrity compliance
  • Establishing SOPs: Getting IT, QA, Supply Chain and R&D on the same page
  • IT, quality management and regulatory affairs: Scaling for speed and efficiency under the Final Guidance on Data Integrity and Compliance with Drug cGMP
  • Mock FDA data integrity audit: Here’s where one learns what FDA investigators will look for vis-à-vis an integrated systems approach
  • Creating an “FDA audit IT SWAT team” for continuous improvement


Due for an inspection? Got a 483 observation or warning letter to remedy? Attend this session.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.

Webinar Details:

Using IT to Improve Data Integrity

Optimizing Your Compliance Joint IT/QA Programs

**An FDAnews/CenterWatch Webinar**

Friday, Sept. 27, 2019, 11:00 a.m. – 12:30 p.m. EDT

https://www.fdanews.com/itdataintegrity

Tuition: $287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/itdataintegrity

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

About CenterWatch:

Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

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Depression and Bipolar Support Alliance Selects PlatformQ Health to Lead New Digital Educational Initiative to Address the Mental Health Crisis


DBSA Logo & PlatformQ Health Logo

DBSA & PlatformQ Health

“Together, we aim to impact millions of patients and families through this initiative so DBSA participants, employer groups, payers, and the general public have easy access to education that improves care.”

The Depression and Bipolar Support Alliance (DBSA), the leading peer-directed national organization for people living with mood disorders, and PlatformQ Health, a premier provider of digital education for clinicians and patients across the therapeutic spectrum, are pleased to announce a new initiative to elevate the way clinicians diagnose and treat mental illness, and empower the millions of Americans who personally face conditions like depression and bipolar to make the best choices for their lives.

“We are thrilled to expand our partnership with PlatformQ Health to create more action-oriented mental health education,” shared Phyllis Foxworth, DBSA Advocacy Vice President. “Since our founding, DBSA has been committed to providing peer-based, recovery-oriented, empowering services and resources when people want them, where they want them, and how they want them. Partnering with PlatformQ Health allows us to leverage their outcomes-centered engagement platform for our education, and deliver convenient and accessible education to clinicians and people living with mental health conditions Together, we aim to impact millions of patients and families through this initiative so DBSA participants, employer groups, payers, and the general public have easy access to education that improves care.”

Over 21 million people in the U.S. live with mood disorders, and these conditions are associated with significant costs. It is estimated that $23 billion are lost in workdays and other workplace losses each year – and far more seriously, suicide is the second leading cause of death among individuals between the ages of 10 and 34, and the fourth leading cause of death among individuals between the ages of 35 and 54. More education is needed to begin turning these tides: peers need to understand the power of peer support, clinicians need to know how best to guide patients in the path toward recovery, and families facing mood disorders need to be able to recognize the symptoms and understand related issues to more readily support loved ones in achieving wellness.

This initiative launches on the heels of successful joint educational programs in Major Depressive Disorder (MDD) that focused on fostering better communication and shared decision-making between people living with MDD and their care teams.

“We live in a data-driven world, where measuring the impact of our efforts is considered key – but somehow, even with all the recent efforts to prioritize outcomes in our healthcare system, the impact of so much health education remains unevaluated,” explained Dr. Wendy Turell, Vice President of Outcomes and Analytics at PlatformQ Health, and member and past chair of the Research Committee at the Alliance for Continuing Education in the Health Professionals. “People facing depression need education that they can understand and apply. They need their doctors to be informed and ready to work together. We are proud to build on DBSA’s legacy of support for people facing mood disorders by creating education that makes changes at scale. Moreover, by evaluating our educational efforts over time, we will be able to see our impact on changes in knowledge, beliefs and behavior among HCP and patient learners.”

Following the initial program, PlatformQ Health supported DBSA’s work with the Milken Institute and released additional education for people living with MDD earlier this year. One of the many conclusions from this impactful study found that a majority of respondents experienced both depression and bipolar symptoms, challenging clinicians’ traditional practice of treating one or the other, and outlining a further need for professional education.

For information about this new initiative, or to receive impact insights from previously launched education, contact us here.

About DBSA

The Depression and Bipolar Support Alliance (DBSA) is a leading peer-focused mental health organization whose mission is “to improve the lives of people living with mood disorders.” DBSA national supports more than 500 support groups and over 200 local affiliate chapters, DBSA reaches over four million individuals with support, educational resources, and tools to help individuals living with mood disorders lead productive and fulfilling lives. Additionally, through our advocacy efforts we amplify peers’ voices and work towards systemic change in the delivery of mental health care.

About PlatformQ Health

PlatformQ Health is the leading provider of interactive digital medical education for clinicians, patients and caregivers. To improve patient care, PlatformQ Health creates video-first educational modules with premier partners, so learners can better understand conditions, available treatment options, and the latest research. The company’s proprietary platform allows participants to engage in real-time discussion with scientific, research and patient care experts – and the integrated learning solution enables advocates, administrators, health systems and plans, foundations, societies, member organizations and associations to measure the impact of their education.

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Dental Insurance Service Shines Bright with Top 5-Star Rating from TopConsumerReviews.com


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Whether you’re looking for traditional insurance coverage or a discount plan, Dental Insurance is your best resource

TopConsumerReviews.com recently gave a best-in-class 5 star rating to Dental Insurance, a leader among online providers of dental insurance plans.

Almost 75 million Americans don’t have dental insurance coverage provided by an employer or by the government. Many of these people pay for their dental costs out of pocket, but those expenses can add up quickly when a simple exam, cleaning, and x-ray can be $100 or more. Fortunately, there are a number of ways to get affordable dental care directly, with the same levels of coverage and options as are available through employers – often using the very same networks and dental professionals. This offers consumers a huge advantage when dental emergencies arise, protecting them from hefty bills in the thousands of dollars for a root canal, broken tooth, or other major issue.

“Whether you’re looking for traditional insurance coverage or a discount plan, Dental Insurance is your best resource,” according to Brian Dolezal of TopConsumerReviews.com, LLC. “There’s no other provider that explains your options so clearly, with an easy-to-use website that will connect you with plans from industry leaders like Delta Dental and Nationwide. Select up to 3 plans to compare and see which one is best for your coverage needs, keeping in mind each plan’s network and time between placing your order and the start date. Dental Insurance is part of Kelsey National Corporation, a reputable company with more than 50 years of experience and an ‘A+’ rating with the Better Business Bureau. Getting the right dental coverage can be overwhelming, but with Dental Insurance you’ll find exactly what you need in no time. We’re pleased to give this company our highest ranking among providers of Dental Insurance plans in 2019.”

To find out more about Dental Insurance and other sources of insurance and discount plans, including reviews and comparison rankings, please visit the Dental Insurance category of TopConsumerReviews.com at https://www.topconsumerreviews.com/dental-insurance/.

About Dental Insurance

Dental Insurance is a wholly-owned subsidiary of Kelsey National Corporation (KNC) with headquarters in Los Angeles, California. A leading provider of dental insurance, this site was the first to enable individuals to both comparison-shop and apply for dental insurance and discount dental plans directly via the Internet. Building on KNC’s dedication to deliver simply the best, Dental Insurance provides families, individuals, and business owners with the easiest way to compare and purchase affordable, quality dental insurance and discount dental plans.

About TopConsumerReviews.com

TopConsumerReviews.com, LLC is a leading provider of reviews and rankings for thousands of consumer products and services. From Dental Insurance to Pet Insurance and Teeth Whiteners, TopConsumerReviews.com delivers in-depth product evaluations in order to make purchasing decisions easier.

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Tyler & Company Named a 2019 Best Place to Work by the Atlanta Business Chronicle


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“This marks our debut to the prestigious ranking from the Atlanta Business Chronicle, and is a testament to the culture, work environment, collaboration and focus we have on our associates and the clients we serve,” said Preston Smith, president of Tyler & Company.

Tyler & Company, a full-service retained executive search firm specializing in recruiting top talent for healthcare, academic medicine, health, and life sciences, today announced it has been named as one of Atlanta’s 2019 “Best Places to Work” by the Atlanta Business Chronicle. The company was recognized alongside other list makers during the publication’s annual awards ceremony earlier this month.

Each year, the Atlanta Business Chronicle invites organizations to take part in its best workplaces survey, which assesses their employees’ perceptions of the workplace and gives insight into strengths and opportunity areas from the employee point of view. Key areas of evaluation include employee engagement, trust in leadership, team dynamics, personal involvement, manager effectiveness, individual needs, and workplace communication and resources.

“Tyler & Company is delighted to be recognized on the 2019 Best Places to Work in Atlanta list. This marks our debut to the prestigious ranking from the Atlanta Business Chronicle, and is a testament to the culture, work environment, collaboration and focus we have on our associates and the clients we serve. I’m very proud of our team, the growth journey we’re on, and the work we’re doing in the rewarding and rapidly-evolving healthcare industry,” said Preston Smith, president of Tyler & Company.

About Tyler and Company

Tyler & Company is a full-service retained executive search firm specializing in recruiting top talent for healthcare, academic medicine, health, and life sciences. Headquartered in Alpharetta, Georgia, the executive search firm’s mission is to provide personalized, high-touch service through experienced and dedicated consultants and vice presidents. Tyler & Company is part of the Jackson Healthcare® family of companies. For more information, please visit http://www.tylerandco.com.

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