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FALLS CHURCH, Va. (PRWEB)
December 20, 2019

Postmarket Problems for Medical Devices: The Path to Resolution

An Interactive Workshop Presented by FDAnews and Ombu Enterprises

Feb. 19-20, 2020 • Hilton Atlanta • Atlanta, GA

https://www.fdanews.com/postmarketproblemsmd

When it comes to dealing with postmarket medical device problems, there is no one-size-fits-all solution. With the US, EU and Canada following different sets of rules, knowing the latest regulatory requirements and complaint processes of each is critical

FDAnews and Ombu Enterprises can help one get more familiar with the regulatory landscape during our two-day workshop in Atlanta this February. During the workshop, attendees will:

*Discover the similarities and differences among US, EU, and Canadian systems and their process flows and decision points

*Determine the function of Quality System Regulations (QSR), ISO 13485:2016, ISO 14971:2019, and their national and regional variants

*Familiarize oneseld with multiple definitions of complaints and their implications

*Identify the characterization of records and reports and how they support regulatory requirements

*Review FDA warning letters and learn how to avoid problems

*Recognize when a design change triggers an updated regulatory submission

*Assess the decisions and timelines for field actions

As a bonus, attendees will also receive a set of Excel workbooks to help follow regulatory paths.

Conference Details:

Postmarket Problems for Medical Devices: The Path to Resolution

An Interactive Workshop Presented by FDAnews and Ombu Enterprises

Feb. 19-20, 2020 • Hilton Atlanta • Atlanta, GA

https://www.fdanews.com/postmarketproblemsmd

Tuition:

Early Bird Pricing: $1,597 (available until Jan. 22, 2020)

Regular Pricing: $1,797 (after Jan. 22, 2020)

Significant team discounts are available.

Easy Ways to Register:

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

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.

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Dr. Anthony Marshall Gacita receiving Associate Fellowship

SARASOTA, Fla. (PRWEB)
December 20, 2019

Dental Care Alliance is proud to recognize Dr. Anthony Marshall Gacita DMD as an Associate Fellow of the American Academy of Implant Dentistry. As one of 750 dentists who hold this distinguished membership, Dr. Gacita is one of the leading experts in implant care. Doctor Gacita maintains the Dental Solutions practice in Voorhees, NJ., providing oral surgery, emergency, implant and children’s dental services.

To qualify for Associate Fellowship, Dr. Gacita completed a minimum of 300 hours of post-doctoral instruction in implant dentistry, performed implant cases and passed the Academy’s Associate Fellow examination. This examination, which is conducted by an expert panel of implant dentists, included a written examination, a series of oral examinations and defense of three implant cases that he had completed. The examination process measured Dr. Garcia’s clinical proficiency in surgical and prosthetic dental implant techniques, in-depth knowledge of dental implants, and commitment to excellence in implant dental practice and to the American Academy of Implant Dentistry’s standards for ethics and patient welfare.

Founded in 1991 and headquartered in Sarasota, FL, Dental Care Alliance supports more than 325 affiliated dental practices in 20 states, making it one of the largest multi-branded dental support organizations in the country. DCA-affiliated practices provide a full suite of dental services, including general dentistry, hygiene, pediatric dentistry, orthodontics, endodontics, periodontics and oral surgery. DCA’s mission is to improve the practice of dentistry by partnering with and supporting dental professionals, so they can create a lifetime of healthy smiles for their patients.

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Success for the Holidays & Autism

You can create detailed social stories, take a trip to the venue beforehand to scope it out, and set up expectations with your child. This not only helps your prepare kiddo, it also helps you determine how to best prepare for the day. – Dr. Regina Crone, Ph.D, BCBA-D, Founder of Therapy and Beyond

DALLAS (PRWEB)
December 21, 2019

“As the end of the year approaches, you may be looking forward to the holiday season as a time to enjoy family, celebrate with traditions, and make lifelong memories. This busy time of year also brings about new foods, faces, and social situations, which can be overwhelming for children on the autism spectrum. Preparing your child with autism, your family, and your friends for these situations can make all the difference in making sure everyone has a “merry and bright” holiday season,” says Dr. Regina Crone, Ph.D, BCBA-D, and founder of Therapy and Beyond, a leading provider of applied behavior analysis and speech services to individuals with autism in TX, OK, and CO.

Many children on the autism spectrum find loud sounds, bright lights, certain textures, strong flavors, and foreign smells to be overstimulating which could provoke a meltdown. Bright blinking Christmas tree lights or a crowded mall may be too overwhelming for your kiddo. Luckily, many seasonal sensory-friendly alternatives are becoming more common every year! Autism trained Santas, specific store hours for soft music and dim lighting, and tree lights that transition smoothly all accommodate those who prefer a sensory friendly environment.

Helpful Hints: Pack a bag including some of your child’s favorite foods, toys or activities. Use this bag to transition from one place to another by using it as a promise. For example, you could tell your child, “Let’s go inside the store and then you can pick out something from the bag.” To visit Santa, let your child include their favorite toy in the picture.

• Success with Family & Friends

If your holiday plans include spending time with family or friends who are not as familiar with your child, discuss your child’s needs beforehand. Be specific! Make them aware of any food aversions, sensitivity to lights or noises, or if your kiddo does not like being touched.

Helpful Hints: Ask if there will be a quiet room available, and explain the possibility of a sudden retreat to take a break in it. There are two reasons preparing those around you before a gathering is beneficial – 1. The more those around your family know about your child’s needs, the easier it will be for them to understand any behaviors that might seem odd or inappropriate. 2. When aware of your child’s needs, loved ones usually do their best to accommodate them.

• Success with Prepping your Child

Many children on the spectrum thrive better in consistent, predictable routines. However, the holiday season usually revolves around unpredictable situations, such as travelling, large group gatherings, as well as changes to eating and sleeping schedules. It’s a good idea to prepare your child for all the ‘new’ they may encounter so they can enjoy the magic in the season.

Helpful Hints: You can create detailed social stories, take a trip to the venue beforehand to scope it out, and set up expectations with your child. This not only helps your prepare kiddo, it also helps you determine how to best prepare for the day.        

Even after you have fully prepared your child, family, and friends to avoid a holiday meltdown situation, the unpredictable can still happen. Have a game plan for when the unpredictable happens. Discuss ahead of time who will be in charge of removing the child from a difficult situation at a family gathering or church. When performing less structured activities, such as shopping or ice skating, determine the protocol if your child gets overstimulated by the music and crowd.

Helpful Hint: Practice plan B with your child and if possible let them practice asking for it appropriately instead of having a behavior problem.

The holidays bring a hustle and bustle that can leave you sprinting through this season. But with these helpful hints and prepping we you will experience the joy of the season with a little less stress.

About Therapy and Beyond

Therapy and Beyond was founded in 2006 on the principal that there is hope for every child. Today, they provide 1:1 individualized ABA therapy for individuals on the autism spectrum in Oklahoma, Texas and Colorado. Applied Behavior Analysis (ABA) is the most commonly prescribed treatment for children on the spectrum, and focuses on expanding functional communication skills, executive functioning skills, and advancing each child’s independence. In addition to helping individuals on the spectrum through ABA, one of Therapy and Beyond’s goals is to find ways to give back to the autism community as a whole, through free events like Mom’s Mingles and Santa’s Helpers Holiday Camps.

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