Technical Writing for Regulatory Submissions

March 08, 2016, Sunnyvale, CA

Overview |  Agenda |  Speakers |  Logistics |  Fees

Overview

Technical writing is not a skill anyone is born with, nor is it something that is typically taught in school. Tailoring your writing for inclusion in regulatory submissions uniquely refines the complexity of this work. Many scientists, engineers and regulatory specialists will model their writing off of previous work they’ve read – ultimately dooming themselves to repeating the mistakes of their peers. Inevitably, this practice sends the organization on a continuous race to the bottom.

Recent changes by the FDA can lead to immediate rejection of your 510(k) notification or PMA application if technical reports fail to meet key requirements. This course will specifically address the needs of medical device companies interested in avoiding interruptions in regulatory review and delays in regulatory approval due to poor or incomplete presentation of engineering information and analysis.

This is an interactive program, complete with real world case studies you can apply to your specific circumstance.

Agenda Topics Include

  • How to clearly state the objective(s) of submission and reports
  • How to identify and plan a clear structure which meets regulatory expectations
  • Tips on writing with clarity and brevity
  • Ways to build a connection with your readers
  • Examples of the appropriate level of technical and regulatory language
  • How to provide an underlying and easy to follow narrative
  • Guidance on clearly stating conclusions supported by data and analyses

Audience

This course is ideal for anyone involved in the creation or review of documents – particularly engineering test reports – used to support submissions and applications to regulatory agencies (like the FDA). R&D Engineers, Design Assurance Engineers and Regulatory Specialists will particularly benefit from this class.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Agenda

Click here to Download.

Speakers

Tony Blank, Cofounder and Senior Advisor, Barton & Blank, LLC

Tony Blank is Cofounder and Senior Advisor at Barton & Blank LLC, a specialized regulatory consulting firm for the medical device and combination products industry. Mr. Blank has served in a variety of roles in the medical products industry - including Clinical and Regulatory - for the past 25 years. Most recently, Mr. Blank spent 12 years at Boston Scientific Corporation in both Corporate and Business regulatory leadership roles, including Vice President of Regulatory Affairs for the CRV businesses (Cardiology, Rhythm and Vascular). Under his leadership, the Boston Scientific obtained numerous regulatory approvals for medical devices and combination products. Among these are world wide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resychronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization.

Mr. Blank has likewise been an active representative for Boston Scientific, the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups – including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired). He is very involved in developing and delivering meaningful educational programs in the field of Regulatory Affairs and has been a regular speaker at educational events. In addition to his time at Boston Scientific, Mr. Blank has worked with Cardiopulmonary, Surgical, Ophthalmic, Vascular Access and Critical Care medical devices.

Hotel & Meeting Logistics

Time: Tuesday, 8:30 am - 4:30 pm; Breakfast and lunch included

Location: Intuitive Surgical
1020 Kifer Rd.
Sunnyvale, CA 94086
Training Room 4 (Bldg 108)

Hotel Recommendations:

Hyatt Regency Santa Clara
5101 Great America Parkway
Santa Clara, California, USA, 95054
408-200-1234
Distance from workshop: 3.7 miles
Website: http://santaclara.hyatt.com/en/hotel/home.html

Santa Clara Marriott
2700 Mission College Boulevard Santa Clara California 95054 USA
408-988-1500
Distance from workshop: 3.5 miles
Website: http://www.marriott.com/hotels/travel/sjcga-santa-clara-marriott/

Embassy Suites by Hilton Santa Clara Silicon Valley
2885 Lakeside Drive, Santa Clara, California, 95054, USA
408-496-6400
Distance to workshop: 2.1
Website: http://embassysuites3.hilton.com/en/hotels/california/embassy-suites-by-hilton-santa-clara-silicon-valley-SNCCAES/index.html

Register for Technical Writing for Regulatory Submissions and FDA Submissions Strategy Workshops and receive a savings of $300 ($150 per workshop).  Email skinchen@advamed.org for the discount code.

Registration Fees

AdvaMed Member Registration: $995.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $1,295.00


Please contact skinchen@advamed.org for Group Discounts.