BEGIN:VCALENDAR VERSION:2.0 PRODID:-//ChamberMaster//Event Calendar 2.0//EN METHOD:PUBLISH X-PUBLISHED-TTL:P3D REFRESH-INTERVAL:P3D CALSCALE:GREGORIAN BEGIN:VTIMEZONE TZID:Eastern Standard Time BEGIN:DAYLIGHT DTSTART:20070101T000000 RRULE:FREQ=YEARLY;BYDAY=2Su;BYMONTH=MM TZOFFSETFROM:-05:00:00 TZOFFSETTO:-04:00:00 TZNAME:Eastern Daylight Time END:DAYLIGHT BEGIN:STANDARD DTSTART:99991231T000000 RRULE:FREQ=YEARLY;BYDAY=1Su;BYMONTH=MM TZOFFSETFROM:-04:00:00 TZOFFSETTO:-05:00:00 TZNAME:Eastern Standard Time END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID="Eastern Standard Time":20191204T080000 DTEND;TZID="Eastern Standard Time":20191204T150000 X-MICROSOFT-CDO-ALLDAYEVENT:FALSE SUMMARY:FDA Update – In Conjunction with ASQ – New England Biomedical Discussion Group & RAPS DESCRIPTION:Collaboratively hosted by the ASQ Biomedical Division/New England Discussion Group\, MassMEDIC and RAPS\, this daylong program is designed to give RA\, QA and C-level executives a one-day crash course on the pending regulatory issues facing the industry. The agenda will include comprehensive presentations by FDA officials\, industry representatives and regulatory experts. Preliminary Agenda\np.p1 {margin: 0.0px 0.0px 0.0px 0.0px\; font: 11.0px Arial\; -webkit-text-stroke: #000000} p.p2 {margin: 0.0px 0.0px 0.0px 0.0px\; font: 11.0px Arial\; -webkit-text-stroke: #000000\; min-height: 12.0px} p.p3 {margin: 0.0px 0.0px 0.0px 144.0px\; text-indent: -144.0px\; font: 11.0px Arial\; -webkit-text-stroke: #000000} span.s1 {font-kerning: none} span.Apple-tab-span {white-space:pre}\n7:30 a.m. Registration / Continental Breakfast / Networking\n8:30 a.m. Session one: Public Policy Update\, Presented by MassMEDIC Topic: The FDA After Gottleib an insider's perspective: Aaron Josephson\, Senior Director ML Strategies and a former senior policy advisor at the Center's For Devices and Radiological Health discusses how the agency has changed\, after the departure of former Commissioner Scott Gottlieb. What can we expect from the agency in 2020 with new leadership. \n10:00 a.m. Networking and Coffee/Snack Break\n10:30 a.m. Session two: ASQ Biomedical New England Discussion Group Topic: FDA New England District Office Update: Joseph Matrisciano\, Jr.\, FDA Director\, New England District gives an annual update on the district offices priorities and Maura Rooney\, SCSO OMDRHO Div. 1\, Stoneham MA Topic: The Pre-Submission Process (and industry anecdotes): David Rothkopf\, President and Lead Principal\, MEDICEPT and Scott Blood Principal Quality and Regulatory Consultant\, MEDICEPT discuss the Pre-Submission Process\n12:00 p.m. Networking Luncheon\n1:00 p.m. Session three: RAPS Boston Chapter Topic: An overview of CDRH's Standards Program: Gail Rodriguez\, Senior Policy Advisor with the Standards and Conformity Assessment Program at FDA's Center for Devices and Radiological Health\, discuses CDRH's Standards Program [including Guidance on the Appropriate Use of Standards and Declarations of Conformity\, and Draft Guidance on the Accreditation Scheme for Conformity Assessment' (ASCA)\np.p1 {margin: 0.0px 0.0px 0.0px 0.0px\; font: 11.0px Arial\; -webkit-text-stroke: #000000} span.s1 {font-kerning: none}\n\n2:30 3:00 pm Wrap up / Q&A\n3:00 p.m. Conference Adjourns X-ALT-DESC;FMTTYPE=text/html:

Collaboratively hosted by the ASQ Biomedical Division/New England Discussion Group\, MassMEDIC and RAPS\, this daylong program is designed to give RA\, QA and C-level executives a one-day crash course on the pending regulatory issues facing the industry. The agenda will include comprehensive presentations by FDA officials\, industry representatives and regulatory experts. \;

Preliminary Agenda

7:30 a.m. \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;Registration / Continental Breakfast / Networking


8:30 a.m.  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;Session one: Public Policy Update\, Presented by MassMEDIC \;


10:00 a.m.  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;Networking and Coffee/Snack Break


10:30 a.m.  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;Session two: ASQ Biomedical New England Discussion Group \;


12:00 p.m.  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;Networking Luncheon


1:00 p.m.  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;Session three: RAPS Boston Chapter \;


2:30 &ndash\; 3:00 pm  \;  \;  \;  \;  \;  \;Wrap up / Q&\;A


3:00 p.m.  \;  \;  \;  \;  \;  \;  \;  \;Conference Adjourns

 \;

LOCATION:860 Winter Street Waltham MA 02451 UID:e.1244.115989 SEQUENCE:3 DTSTAMP:20191207T141217Z URL:https://business.massmedic.com/events/Details/fda-update-in-conjunction-with-asq-new-england-biomedical-discussion-group-raps-130342?sourceTypeId=Hub END:VEVENT END:VCALENDAR