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The Quality System Regulation Webinar Series

Webinar 1 of 9. View Archive

About the Webinar Series

Manufacturers of finished medical devices sold in the U.S. are required to develop a quality management system appropriate for their organization, processes, and product risks. The Quality System Regulation (QSR) is both a legal requirement and a powerful set of principles that can help companies improve procedures and products, and ultimately the bottom line.

All device company employees should possess a working grasp of those aspects of the QSR and related regulations that pertain to their job responsibilities.

Simple in concept, the QSR requirements can be daunting in their interpretation and implementation. It is important not only to understand what the regulations and guidance documents say, but the rationale behind them, and the practical challenges of developing, establishing, maintaining, and monitoring quality procedures.

This 9 part QSR webinar series provides a comprehensive overview of the Quality System Regulation and related topics.

Webinar 1: The Quality System Regulation (QSR)
Friday, January 17, 2014  12:00 PM – 1:30 PM  EST

Webinar 2: Design Controls
Friday, February 7, 2014  12:00 PM – 1:30 PM  EST

Webinar 3: Purchasing Controls
Friday, February 28, 2014 12:00 PM – 1:30 PM  EST

Webinar 4: Production and Process Controls
Friday, March 21, 2014  12:00 PM – 1:30 PM  EST

Webinar 5: Corrective and Preventive Action (CAPA)
Friday, April 11, 2014  12:00 PM – 1:30 PM  EST

Webinar 6: Complaint Handling
Friday, May 2, 2014  12:00 PM – 1:30 PM  EST

Webinar 7: MDRs, Reports of Corrections & Removals, and Recalls
Friday, May 23, 2014  12:00 PM – 1:30 PM  EST

Webinar 8: Documentation
Friday, June 13, 2014  12:00 PM – 1:30 PM  EST

Webinar 9: Inspections and Enforcement Actions
Friday, June 27, 2014  12:00 PM – 1:30 PM  EST


  • For small companies – For smaller medical device companies, where every employee wears multiple hats, these modules provide a concise, convenient, comprehensive overview of key rules that govern this regulated industry.
  • For new hires – this information is a valuable supplement to in-house orientation.
  • For those in transition – for people just entering regulatory or quality, or coming to devices from another regulated industry, this series introduces the unique regulatory stance on the device industry and its products.
  • For those maintaining the Regulatory Affairs Certification (RAC) credential – 1.5 RAC credits are earned per webinar.  13.5 RAC credits are earned for watching the entire series.
  • For all those who need to maintain training and continuing education credits: Each Single-webinar Registrant will earn 0.15 CEUs per webinar. Each Full-series Registrant will earn 1.35 CEUs


  • How and why quality should be controlled by medical device manufacturers
  • FDA regulatory and quality responsibilities that all employees should know
  • The Quality System Regulation and related regulations and guidances
  • Documentation requirements and best practices
  • Principles of complaints and reportable events
  • Rules and best practices for inspections
  • Resources for further information


A Moment for Accuracy

Like most, I appreciate how quickly we get information these days, but at the same time, I am seeing an unfortunate trend – typos, nonworking links, wrong information and other content errors or functional mistakes on tweets, blogs, emails, etc.

During the past several weeks, I had to refrain from retweeting a number of interesting items because they had typos in them and links that did not work. One organization retweeted what they thought was a corrected link, but it still did not work. Even major news organizations are often issuing corrections to their alerts. In the quest to be first, accuracy is being lost and embarrassment is becoming more prevalent.

Maybe it is just me, but I have always placed a premium on accuracy. This was drilled into me by every grammar teacher I had throughout elementary school and high school. The quest for accuracy was further honed by my college journalism professors and the newspaper editors I had when I was a reporter. At my first public relations job, the policy was three sets of eyes, including a formal copyeditor, had to review or proof anything before it went out.

Proofing and fact checking is just part of me, I cannot help it. It is part of almost everything I do, especially in business. This is not to suggest that I have never made a mistake. However, I try to do everything possible to keep errors and embarrassment to a minimum. Here are some simple things I do to prevent errors.

1)    Research – Make sure you have the facts, check with reliable experts when writing a post or anything else.

2)    Review – Have a colleague or friend review what you have written for accuracy and tone. Depending on the seriousness of the item, have several people review. Everyone has a different perspective, and there can be multiple reactions to what you have written.

3)    Wait – Do not rush to post something the minute it is done. Let it sit a couple of hours or a day and take a second look at it with fresh eyes.

4)    Recheck – When you are ready to post or tweet, make sure everything is accurate and check that your links work before you send it.

Let me know what you do to maintain accuracy.


How to Work with a Voiceover Artist

When hiring a voiceover (VO) artist for a commercial, PSA, film or other project, you most likely will get recommendations and voice samples of trusted professionals from your production team. Once you have selected a voice that you like, you can finish the script, book the studio time and begin laying down tracks.

According to Steve Taylor, a DC-area VO artist, author and longtime reporter for national news radio networks including Fox, ABC and CBS, a professional VO artist will help you use your studio time productively and help you get the result you want and need.

Be Specific

“When in the studio, be as specific as you can about what you want. Do you want the voiceover to sound like a newscaster, narrator or other style? If there’s an actor or other public voice that you like, mention it,” says Taylor. “If you are not exactly sure what you want, ask the voiceover artist who can advise you. There are an infinite number of deliveries possible, more choices than you think.”

Try Different Readings

“A good voiceover artist can do many different ‘readings,’ by which I mean the ways the words are delivered. Different readings can provide useful shades of meaning,” says Taylor noting that voiceover artists are also actors. “A good voiceover artist can do many different ‘voices,’ adjusting his or her voice for accent, apparent age, vocal pitch, speed of speech and so forth. Whatever the role requires.”

Get Extra Takes

Although a professional can usually nail a script in the first few takes, it is a good practice to ask for a variety of readings of the same script. A half-day rate is typical whether the voiceover artist is in the studio for 30 minutes or a few hours, so feel free to utilize his or her talent.

When in Doubt, Experiment

Taylor enjoys working with people who sometimes are not sure what they want exactly or like to experiment with some approaches to see what they can create.

“A professional understands and enjoys collaborating. I like to try different readings of the same material. Sometimes you find something unexpected that you like and can build upon,” says Taylor, who has done voiceovers for commercials, films and more. “Keep asking for more until you get what you want, or until it’s clear you have heard all the readings and voices the artist can give.”

It’s OK If You Don’t Like Something

According to Taylor, professional voiceover artists should never be offended if you do not like a take. They understand it’s business, not personal.

“If you know a reading is wrong but don’t know how to make it right, simply ask for another reading. The artist may provide an approach better than any you’ve thought of. Also, if you want another type of voice, ask for the artist to suggest one,” explains Taylor.

Don’t Say Cut

“When doing takes, especially short ones, it is best to let the artist finish. After he or she is done, explain if you didn’t like something. Also, if you heard something you did like, say ‘do more of that.’ This will save time and money editing later on,” says Taylor noting that when doing a longer narration, it is OK to interrupt and start over.

Tweaking the Script

“When hiring a voiceover artist, you are not hiring a writing coach, but sometimes voiceover artist can give good coaching on a script, especially if the narration is still evolving during the recording session or if something just doesn’t seem to be working once you are in the studio,” says Taylor, who has been writing and delivering scripts for radio newscasts for several decades.

“Scripts need to be written for the ear, not the eye. This means writing short, active-verb sentences,” notes Taylor.  “The best way to write for the human voice is to read aloud what you have written. Did you like what you heard? Read it aloud to others. Did they understand what you were trying to convey?”

After the project is finished, email the audio track to the voiceover artist, so that he or she can keep a record of the successful reading and voice. This will save time if you decide to use the same artist again.





Sanders Featured on Huffington Post

In his Huffington Post article, “The High Court’s Brisk Constitutional: Health Reform,” Alain L. Sanders, associate professor of political science at Saint Peter’s College in New Jersey, writes:

If ever there was a get-out-of-town case, this one is it: Department of Health and Human Services v. Florida, the case that challenges the constitutionality of President Obama’s health care reform law. The justices can be expected to make a quick dash for the exits once they announce their decision, most likely at the end of the Court’s term in late June.

Read Full Article


Five Tips to Optimize Your Web Presence

Tip 1:

“It’s all about meaningful content,” says Mike Conaty, president of Brunswick Media Services LLC, a web marketing and video production company.  “The most important thing you can do is provide useful and interesting information so that you attract visitors to your site, get them to come back often and get them to share your content with their connections.”

Tip 2:

According to Conaty, the next critical strategy is to provide fresh information on your website continually by writing original content on your blog post, sharing interesting articles from others or providing links to other sites and resources. “People especially like a short list of tips with tactics they can start using right away. You want to be a resource,” Conaty points out. “The worst thing you can do is treat your website like a brochure.”

Tip 3

Once you have meaningful content, Conaty says spread the word by being active in social media – LinkedIn, Twitter, Google+, YouTube, Facebook and whatever platforms make sense for your organization. “The goal is to develop a following and expand your contact base so that you can grow your business, promote a cause or achieve whatever goal you want to accomplish,” notes Conaty (@BrunswickMedia).

Tip 4

“The biggest pitfall to avoid is writing for the search engines by cramming in so many key words into a post or page that is it incomprehensible,” says Conaty. “This doesn’t work and the search engines penalize you for trying to trick the system this way.  Believe it or not, the search engines are looking for meaningful content too, which is the best way to raise your web presence.”

Tip 5

If you do not have the time, capability or staff to manage your website and social media presence, or just need help getting started in a new direction, contact a web marketing professional. Conaty recently updated and expanded our social media presence. We also joint venture on client projects. For more information, contact Mike Conaty or Patty Murray.



Aphasia-Friendly Businesses

In the article, Living Life with Aphasia and Feeling Included, by the dis-Abilities Celebration Network, aphsia-friendly businesses were profiled. Here is an excerpt.

The Aphasia-Friendly Business Program, which began in January 2011, is about to be launched in select cities and states through the NAA. So far, the effort will expand to New York City, Long Island, Orlando, Nashville, Hayward, CA, Ohio and Kentucky.

“It’s a win-win for people with aphasia, who shop as part of everyday life. For business owners, it’s a way to attract more customers, serve every- one better by providing reasonable accommodations, and create a welcoming, community-oriented environment,” says Ellayne Ganzfried, CCC-SLP, executive director of the NAA. “The aphasia- friendly business materials can also be useful to those that have other communication barriers, like not speaking English. As business owners and their staff are trained, they in turn can teach other people,” she says.

Read Full Article (Page 5) by Carrie Smoot

NAA’s Ganzfried Featured in Article

In the Society for Human Resource Management article on How Employers Gain Access to Talent with Brain Injuries, aphasia was addressed. Here is an excerpt.

For many people, TBI brings on aphasia, a communication disorder that impairs their ability to process language, noted Ellayne Ganzfried, executive director of the National Aphasia Association in New York. Those with the disorder might have trouble speaking and they might seem as if they don’t understand things they hear or read.

However, “aphasia does not impair intelligence,” Ganzfried said. “You still retain the essence of who you are.” She said people with the disorder can perform a variety of tasks such as data entry, online research or bookkeeping.

Read Full Article by Stephenie Overman

Molecular Diagnostics: Translation from the Bench to the Clinic

Molecular diagnostic tests involve analyzing the DNA, RNA or proteins of an organism to identify molecular signatures of disease (biomarkers) or to evaluate the predisposition of an individual for a disease. The results of these tests influence clinical decision-making so assuring their sensitivity and specificity is of utmost importance. Current Protocols and Thermo Scientific NanoDrop Products are pleased to present a FREE 1-hr webinar by two leaders in molecular diagnostic test development.

Dr. Joshua LaBaer, Director of the Piper Center for Personalized Diagnostics at the Biodesign Institute at ASU, will describe the approach to developing molecular diagnostics tests, their applications, their relative strengths and shortcomings, how to select appropriate methods or combinations of methods for particular research problems, and critical aspects of test performance and validation.

Dr. Wayne Grody, Director of the Diagnostic Molecular Pathology Laboratory at the UCLA Medical Center, will then describe some examples of translation of molecular diagnostic methods from the bench to the clinic, including the critical issues of quality assurance, ethical controversies, and regulatory compliance in testing for both common and ultra-rare (“orphan”) diseases.

What you will learn:
•Strengths and weaknesses of various molecular diagnostic methods
•How to select appropriate methods and combinations of methods for a particular problem
•About controls and how to evaluate the reliability of molecular diagnostic assay results
•About the contrasting challenges of analytic vs. clinical validation of new tests
•About critical regulatory and ethical aspects of clinical molecular diagnostics testing

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Angiotensin Receptor Blockers: Pharmacology, Efficacy, and Safety

The renin-angiotensin-aldosterone system (RAAS) plays an important role in protecting vertebrates against cardiovascular collapse due to hypotension and volume loss in the event of traumatic injury that involves blood loss. In certain humans, however, inappropriate or exaggerated activity of the RAAS contributes to the development of hypertension and the initiation of a molecular cascade in tissues with consequent injury to critical organs such as the brain, kidneys, heart, and blood vessels.As understanding of the pathologic role of the RAAS in hypertensive vascular disease has unfolded during the past century, so has the interest in developing drugs that could interdict specific components of the RAAS. The first of the RAAS-blocking drugs to become commercially available were the aldosterone antagonists in the 1970s, followed by the angiotensin-converting enzyme (ACE) inhibitors in the 1980s and the angiotensin II receptor blockers (ARBs) in the 1990s. Unlike ACE inhibitors that inhibit the conversion of angiotensin I to II, ARBs bind to the angiotensin II AT1 receptor, thereby inhibiting the cellular actions of angiotension II mediated by the receptor in which the tissue is located. During the past 20 years, studies in the laboratory and clinic have documented that ARBs, either alone or in combination with drugs of other classes, reduce blood pressure (BP) in hypertensive animals and humans; reduce rates of myocardial infarction (MI), stroke, and progression of renal impairment; and positively impact other markers of cardiovascular (CV) events such as left ventricular hypertrophy (LVH) and urinary protein excretion independent of their effect on BP. Although improvement in mortality and morbidity has been demonstrated after treatment of patients with congestive heart failure (HF) and following MI, this review paper will focus primarily on evidence supporting the use of ARBs in the management of hypertensive patients with and without comorbidities.

Accreditation and Designation Statement

Blackwell Futura Media Services designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Blackwell Futura Media Services is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Educational Objectives

• Discuss the current clinical research in hypertension that adds to the body of scientific evidence in the treatment of patients with hypertension.

• Apply their awareness and knowledge of current clinical research and scientific evidence that will contribute to the overall care of patients with hypertension and other cardiovascular disease factors.

• Discuss the efficacy, safety, and tolerability of the different pharmacologic treatment modalities that modulate the renin-angiotensin-aldosterone system to reduce blood pressure and mitigate the negative consequences of poor blood pressure control.

• Identify high-risk patient characteristics and determine optimal therapy to achieve target blood pressure.Jump to…Top of pageAccreditation and Designation StatementEducational ObjectivesActivity DisclosuresInstructions on Receiving Credit

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Evaluation and Implementation of Rapid Microbiological Methods: A Case Study for an Alternate Sterility Test

Evaluation and Implementation of Rapid Microbiological Methods

A Case Study for an Alternate Sterility Test

In this complimentary webinar, you will learn step-by-step, the major considerations for evaluating and implementing a Rapid Microbiological Method in your organization. The focus of the 60-minute discussion will be a real case study by a major pharmaceutical leader that recently implemented an RMM as an alternate sterility test. By attending this webinar live or on demand, you will…

– Gain insights into the company’s business-decision process and getting buy-in from the management team

– Discover what the company learned from its review of available RMM technology

– Understand the company’s comprehensive Master Validation Plan, which included:

– IQ, OQ, PQ
– Non-inferiority Study
– Equivalence Analysis
– Method Validation

– Hear the critical lessons learned by the company, which will save you time and money

Webinar Speakers

Ron Smith, Ph.D.
Wavefront Consultants

Philippe Gadal
CEO AES Chemunex

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