Welcome to the November 2020 chapter newsletter. Let us know what you think, and remember, you can also read it on the chapter website. You can find previous newsletters on the website as well. And we always welcome suggestions for newsletter topics.

In this issue:

CHAPTER EVENTS

• Virtual Winter Happy Hour, December 3rd, 2020 from 6 – 7 pm – via Zoom.

• Discussion Panel: Transitioning to Medical Writing, January 14th 2021from 6 – 7 pm – via Zoom.

• Next Book Club: Monday, January 25th, 2021 via Zoom

NEWS

• Urgent need for a candidate for chapter president-elect! Submit nominations by November 15th. See details below.

• Take an Active Role! Please consider volunteering!

FEATURES

• Book club notes

CHAPTER EVENTS

Virtual Winter Happy Hour

Beat the winter blues by joining AMWA’s virtual happy hour event from 6-7pm on Thursday, December 3rd 2020 via Zoom. Participants will contribute to the discussion on coping with our new normal, including topics such as virtual tools, networking tips, new hobbies, work, and lifestyle changes/adaptations. Non-members are welcome to attend with a member invitation to learn more about AMWA and use this opportunity to ask questions. Hope to see you there!

Please RSVP here or email Messac at programs (at) amwanorthcentral (dot) org to register. Zoom Meeting ID: 927 4320 2328

Discussion Panel: Transitioning to Medical Writing

Hear from a wide-ranging panel of medical writers on their experience in the medical writing field including what it takes to succeed, how to find/secure jobs, and the pros and cons of each position. We are thrilled to have a panel that includes members from diverse medical communication practices with about a century of combined experience, which allows us to learn about the various career options in the field. The panel member details will follow in the December newsletter. Mark your calendars!

Please RSVP here or email Messac at programs (at) amwanorthcentral (dot) org to register. Zoom Meeting ID: 988 8628 4936

Book Club hosted by Paul Mamula

Topic: Deadliest Enemy: Our War Against Killer Germs by Michael T. Osterholm and Mark Olshaker

When:  Monday, January 25th, 2021 at 11:00 am Central Time via Zoom

Details:  We will be reading the second edition (2020), which has a new section about the COVID-19 pandemic. The book is nontechnical and an easy read. It traces many diseases and also includes stories about Michael Osterholm’s life and career. See you there!

RSVP: By 9 a.m. the morning of January 18th, please email Book Club coordinator Paul Mamula to let him know you will attend: paulpat (at) pclink.com.

Look for details on the Zoom meeting in future newsletters.

NEWS

Take an active role in AMWA – Volunteers needed!

The AMWA North Central chapter is looking for a new president-elect. The president-elect position is critical to our status as a chapter!  Without a volunteer to fill this vital position, we will not be able to continue as a chapter. Please volunteer!

AMWA North Central is a volunteer-based organization. If members don’t take an active role, the chapter will cease to function, and members will lose access to programming, news, and networking opportunities. Consider taking your turn to lead (or join) a committee or serve as a chapter officer.

President-elect: The new president-elect role will serve a one-year term beginning in February 2021 and ideally will transition into the role of president in 2022. As president-elect, you will attend the monthly AMWA NC chapter board meetings, take minutes, and chair the meeting if the president is unable to attend. Other duties may be assigned by the president or board on an ad hoc basis. Please submit your nominations by November 15, 2020 to president (at) amwanorthcentral (dot) org.

In addition to keeping our group viable, volunteering with AMWA is a great way to network with your fellow members. It’s also a good way to fortify your C.V. with an extra line showing how you give back to your profession! If you can volunteer a few hours a month to help, contact our president, Michele Cleary: president (at) amwanorthcentral (dot) org

FEATURES

Reflections on working in a regulated industry

By Kendra Hyland, PhD

It was a big change for me to move from an academic environment to a company in a regulated industry (e.g., medical device). There are many rules that one must follow when working at a regulated company that are not necessary in academics. The FDA requires that employees at these companies are appropriately trained and regularly complete their training on-time [1].  Also, the FDA requires evidence that employees are qualified to hold their position through experience or education[2].  

In the case of medical devices, a primary driver throughout the entire lifecycle of products, which includes the device, labeling, and packaging, is compliance to standards, directives, and regulations. International standards and country-specific regulations describe the requirements for testing, clinical investigation, packaging, labeling, marketing, distribution/storage, post-market monitoring, etc. for medical devices.  US regulations and international standards [3] describe the quality management system, which is the group of processes that must be followed during product development. To develop a new medical device, companies must follow the steps described in the US Code of Federal Regulations (CFR, Sec 820.30 Design Controls). [4]  The steps are not described in much detail in the CFR, and each company generates internal standard operating procedures (SOPs) that employees must follow, governed by a quality management system.  

Standards or regulations may have multiple interpretations. It is important to be familiar with guidance documents that help interpret standards or regulations. The FDA and the European Commission as well as industry organizations author guidance documents. FDA guidance documents do not have the force of law and are not obligatory. European guidelines are also not legally binding but they are in practice obligatory. A company may choose to comply to guidelines as a smart course of action.[5]

In order to show compliance to the standards and regulations, much documentation is required.  Each step of the medical device development process (and labeling/ packaging) must be documented, and these documents are reviewed and approved by a team of cross-functional experts.  Depending on the role in the company, a significant part of employee time may be spent writing these documents and sending them out for review and input, either virtually or in face-to-face meetings with members of the project team. If you dislike paperwork or attention to detail is not a strength, then this is something to consider when you are considering a move to a regulated industry.

Both internal and external audits take place frequently to determine if documentation follows the company’s quality management system as well as standards and regulations. Any issues or deficiencies identified in an audit typically require urgent attention.  In addition, audit findings may lead to changes to work process or tasks. Particularly in large companies, change is a constant. There may be shifts in work priorities as regulatory, audit, and business needs are taken into account.

Working in a regulated industry is never dull. Through your efforts, you contribute to approval for devices that help patients on the market. And who knows? The patient could be you or a loved one, making the work personal.

[1] Employee training

[2] US Code of Federal Regulations Title 21 Part 820.25

[3] ISO 13485 and US Code of Federal Regulations Title 21 Part 820 

[4] US Code of Federal Regulations Title 21 Part 820.30 Design Controls

[5] Laws, Regulations, Guidances, Guidelines, and Best Practices