The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to...

Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the FDA to establish rules to improve, audit and enforce new food transportation rules. The rules provide a significant focus on foods not completely enclosed by a container, risk reducing adulteration prevention, pers...

When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rathe...

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes: Design and TPP Pre-clinical testing and comparability Clinical testing Analytical studies Stability of biosimilar products Why you should attend: The regulation of Biosimilars is very complex and the approach used by various regions differs. Professi...

The president issued an executive order (EO) on March 17, 2017 which requires agencies to plan and implement long-term workforce reductions and incorporate the plan as a government-wide workforce priority into their Agency Strategic Plan and/or Human Capital Operating Plan. This Potomac Forum training workshop for government will provide information for agency executives, managers, and staff to respond to the EO. Experienced human capital exe...

Please join Gigamon and our partners for the 2nd Annual Public Sector Cybersecurity Summit. This half day event will feature a keynote address by former National Intelligence Director James Clapper, plus sessions on best practices and insights from government CISOs and cybersecurity practitioners. The Summit includes breakfast, lunch and networking opportunities.

SEMINAR SERIES in Miami FL DECEMBER 2016 EAR Export Controls / ITAR Defense Trade Controls Seminar Series at the Doubletree Ocean Point Resort & Spa 17375 Collins Avenue, Miami Beach, FL 33160 REGISTER NOW DOWNLOAD SEMINAR BROCHURE EAR & OFAC Controls SEMINAR SEMINAR AGENDA ECoP® EAR renewal credits = 4 DEC 5-6, 2016 USD $1175 ITAR Controls SEMINAR SEMINAR AGENDA ECoP® ITAR renewal credits = 4 DEC 7-8, 2016 USD $1175 BOTH SEMIN...

SEMINAR SERIES in Miami FL DECEMBER 2016 EAR Export Controls / ITAR Defense Trade Controls Seminar Series at the Doubletree Ocean Point Resort & Spa 17375 Collins Avenue, Miami Beach, FL 33160 REGISTER NOW DOWNLOAD SEMINAR BROCHURE EAR & OFAC Controls SEMINAR SEMINAR AGENDA ECoP® EAR renewal credits = 4 DEC 5-6, 2016 USD $1175 ITAR Controls SEMINAR SEMINAR AGENDA ECoP® ITAR renewal credits = 4 DEC 7-8, 2016 USD $1175 BOTH SEMIN...

The Office of Management and Budget (OMB) Circular A-123, Management's Responsibility for Enterprise Risk Management and Internal Control was recently revised on July 15, 2016. Besides replacing the title, Management’s Responsibility for Internal Control the Circular requires integration of Enterprise Risk Management (ERM) into the internal control framework, requires agencies to implement ERM capabilities and engages all agency managem...

SEMINAR SERIES in Phoenix AZ NOVEMBER 2016 EAR Export Controls / ITAR Defense Trade Controls Seminar Series at the Sheraton Crescent Hotel 2620 W. Dunlap Avenue, Phoenix, AZ 85021 REGISTER NOW DOWNLOAD SEMINAR BROCHURE EAR & OFAC Controls SEMINAR SEMINAR AGENDA ECoP® EAR renewal credits = 4 NOV 14-15, 2016 USD $1175 ITAR Controls SEMINAR SEMINAR AGENDA ECoP® ITAR renewal credits = 4 NOV 16-17, 2016 USD $1175 BOTH SEMINARS SAVE $200...