Winter Meeting Date & Time: 24-Feb-17 9:00am 3:30 pm – – Location: PTC Therapeutics, Inc., 100 Corporate Court South Plainfield, NJ 07080 ▪ ▪. Access Website: Time AGXPE WINTER MEETING, 24FEB2017 Presented by: Coffee and Networking 8:30 9:00 a.m. – Welcome and Logistics John Lewis CEO, AGXPE 9:00 9:15 a.m. – – Chrissy Frey Director, Compliance Learning, 9:15 9:30 a.m. – – and Stuart W. Peltz, CEO, PTC Therapeutics, Inc. Are You Ready? FDA’s Review” Approach to Teresa Gorecki, Practice Lead, Compliance 9:30 10:30 a.m. “Live – Inspecting Quality System Documentation Architects LLC Networking 10:30 11:00 a.m. – Contamination Control in Manufacturing: Safety & Patrick President, Skillpad Canada Inc. 11:00 a.m. to 12:00 p.m. Quality Management of Foreign Object Debris an – Aerospace Industry perspective Lunch 12:00 1:00 p.m. – David Young, Dir. Regulatory Affairs, CMC Discussion: 1:00 2:00 p.m. Christine LaRock, Dir of Clinical Development – Data Integrity a Global Perspective – PTC Therapeutics, Inc Bijal Shah, Associate Director, Clinical Data Management Early Development, Merck – Research Laboratories Vince Ranieri, Manager, Laboratory Analyst Training & Certification Program, Johnson & Johnson Bristol-Myers Squibb. Santosh Tharkude, Associate Director, ERES Compliance Networking Break 2:00 2:30 p.m. – Training Strategies to Promote Learning Chrissy Frey, Director, Compliance 2:30 3:30 p.m. – Learning, PTC Therapeutics, Inc. Meeting Close John Lewis, CEO, AGXPE, 3:30 3:45 p.m. – Organization Update: Future Meetings, Board of Directors Sponsors, Topics
Winter Meeting Date & Time: 24-Feb-17 – 9:00am – 3:30 pm Location: PTC Therapeutics, Inc., 100 Corporate Court ▪ South Plainfield, NJ 07080 ▪. Access Website: AGXPE WINTER MEETING, 24FEB2017 Presented by: Time Coffee and Networking 8:30 – 9:00 a.m. Welcome and Logistics John Lewis – CEO, AGXPE Chrissy Frey – Director, Compliance Learning, and Stuart W. Peltz, CEO, PTC Therapeutics, Inc. 9:00 – 9:15 a.m. 9:15 – 9:30 a.m. Are You Ready? FDA’s “Live Review” Approach to Inspecting Quality System Documentation Teresa Gorecki, Practice Lead, Compliance Architects LLC 9:30 – 10:30 a.m. Networking 10:30 – 11:00 a.m. Contamination Control in Manufacturing: Safety & Quality Management of Foreign Object Debris – an Aerospace Industry perspective Patrick President, Skillpad Canada Inc. 11:00 a.m. to 12:00 p.m. Lunch 12:00 – 1:00 p.m. Discussion: Data Integrity – a Global Perspective David Young, Dir. Regulatory Affairs, CMC Christine LaRock, Dir of Clinical Development PTC Therapeutics, Inc Bijal Shah, Associate Director, Clinical Data Management – Early Development, Merck Research Laboratories Vince Ranieri, Manager, Laboratory Analyst Training & Certification Program, Johnson & Johnson Santosh Tharkude, Bristol-Myers Squibb. Associate Director, ERES Compliance 1:00 – 2:00 p.m. Networking Break 2:00 – 2:30 p.m. Training Strategies to Promote Learning Chrissy Frey, Director, Compliance Learning, PTC Therapeutics, Inc. 2:30 – 3:30 p.m. Meeting Close Organization Update: Future Meetings, Sponsors, Topics John Lewis, CEO, AGXPE, Board of Directors 3:30 – 3:45 p.m.