Tuesday 21 May 2013

About Marc C. Sanchez

 

Publications

Articles

  • Top Food Observations 2011, AIB International Monthly Newsletter (Jan. 2012)
  • Ancestry of the Food Safety Modernization Act, cover feature Food Safety Magazine (Aug. 2011 Ed.)
  • US Food Safety Reaching to China, China Law Blog (Apr. 8 2011)
  • Shifting Sands of Social Medical, SHRM (Nov. 2011)
  • Quoted in High Load, Low Bridge, American Shipper Magazine (May 5, 2011)
  • Employee Privacy and the use of Social Media, WA Bar News (cover story Apr. 2011 Ed.)
  • Founder and Editor Food Court: food law blog, Jan. 2011-present (www.foodct.com)

Interviews

  • Keynote address at Food Manufacturing and Safety Forum (Dallas, TX)
  • Food Safety Rules Tied To FSMA May Be Ignored By Industry, Huffington Post (featured interview, January 2013)
  • The new pink slime? Beetles in Starbucks frappuccinos anger consumers, Washington Post (March 2012)
  • Should Medical Device Companies Pursue Regulatory Approvals in Europe Before the US?, Medsider (March 2012)
  • Panel: Open up meat, egg inspection data, Argus Leader Interview (December 2011)
  • Will FSMA Require Food Producers to Test their Products? AME Food Testing Show (November 2011)
  • Preventing Bacterial Pathogens in Food Packaging, AME Food Testing Show (October 2011)
  • Social Media is a Game Changer for Business Hiring, Business News Daily (Apr. 27, 2011)

Webinars and Presentations

  • FDA Form 483 Best Practices, California Almond Board Food Quality and Safety Symposium (Aug. 2012)
  • Food Safety Modernization Act Update – What’s New and How to Comply, MetricStream (July 2012)
  • The PIP Scandal – Will It Impact EU Medical Device Regulations?, FX Conferences (May 2012)
  • The Foreign Supplier Verification Program and What it Means for the Food Industry, FX Conferences (Apr. 2012)
  • Presentation, Social Media and the Law Firm, Atlanta ALA (June 2011)
  • Presentation, Social Media and Public Employees, at the WA State Municipal Attorneys Conf.(Apr. 2011)

Experience

  • Compliance consulting – FDA (medical device, food, dietary supplement), USDA and APHIS (importing livestock), DOE, CPSC compliance, facility inspections, aduit findings, revising operating procedures, developing product and/or food recall manuals, filing agency reports, training employees.
  • Counsel corporate clients on updating and creating social media policies and other corporate governance
  • Consultant to corporate clients on start-up, tax, and risks of new ventures
  • Advise employers on internal investigations and termination issues involving social media
  • Litigation practice focused on defending on defending decisions involving misuse of technology or violating company policies through social media

Education

  • Lewis and Clark Law, Portland OR: J.D. May 2010 (top 25%) Law Review:  Environmental Law
  • Valparaiso Univ., Valparaiso, IN: M.S. in Int’l Comm. & Policy, December 2007 (summa cum laude)
  • Univ. of New Mexico, Albuquerque, NM: BBA, Finance, May 2006 (cum laude)

 Portfolio of Recent Work

  • Counseled start-up on formation, FDA establishment registration, device listing, and 510(k) & international device approval (EU, China, Japan etc.);
  • Reviewed label for dietary supplement maker for compliance issues;
  • Special 510(K) Application for modification to an approved polymacon lens;
  • Color Certificate for adding new “listed” color additives to colored lenses;
  • Form 483 and Warning Letter response for lens manufacturer and importer, including updating SOPs (device labeling, receiving activities, complaints and MDRs);
  • Managed multi-purpose solution recall due to misbranded country of origin;
  • Worked with FDA on behalf of lens manufacturer who failed to timely track consumer complaint (filed a MDR out of an abundance of caution);
  • Pre-IDE IVD Submission (and 513(g) application) for non-invasive molecular diagnostic for color blindness (genetic test); and
  • EU IVD application for non-invasive molecular diagnostic for color blindness (genetic test).

Member of RAPS


(Learn More Here)

 

 

 

Powered by WordPress. Genius Design by MCS.