PDA Metro Chapter: Chapter Day

Basking Ridge, NJ
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The PDA Metro Chapter is offering an incredible event called 'End to End Inspection Readiness Regulatory Inspections.' This event will provide you with all the necessary knowledge to prepare, respond to, and complete regulatory inspections successfully.

You are cordially invited to attend this event on September 27, 2023, from 8:00 am - 4:00 pm EST.

We hope to see you all there!

Event Location
225 Route 202, Basking Ridge, NJ Get Directions

Contact

Chapter Inquiries
Tel: +1 (301) 656-5900
Membership Services

Standard Pricing

Standard Member Price

$300.00

Non-Member

$400.00

See Qualifying Criteria for Member Types.

Day 1

  • 8:00 am - 8:45 am | Continental Breakfast, Registration and Vendor Show
  • 8:45 am - 9:00 am | Welcome & Announcements
  • 9:00 am - 9:45 am | Quality Expectations for Big Pharma and Small Pharma, Seth DePasquale, RPh, Sterile Compounding Pharmacist, Consultant, PharmaComp.ly
  • 9:45 am - 10:30 am | Review of Recent Inspection Trends, Michael Klapal, Compliance Officer, FDA/CDER/OC/OMQ
  • 10:30 am - 10:45 am | Morning Break
  • 10:45 am - 11:25 am | Global Inspection Readiness, Michael London, Head of R&D Quality, Daiichi Sankyo
  • 11:25 am - 12:15 pm | Data Protection, Luciana Sartor L. Mansolelli, Regulatory Compliance Head, J&J
  • 12:15 pm - 12:45 pm | Lunch/Group Pictures
  • 12:45 pm - 1:45 pm | During this Interactive Lunchtime Presentation, Robert Seltzer will interview Jim Agalloco, President, Agalloco & Associates, on topics to assist any company prepare for Regulatory Inspections: All Things Life Science Process Validation, especially Sterilization Process Validation. Moderator: Robert Seltzer
  • 1:45 pm - 2:30 pm | Pre-Approval Inspection Toolbox, Eric Thostesen, Senior Director, Compliance, J&J
  • 2:30 pm - 3: 00 pm | Annex 1, Madison Hoal, Global Technical Consultant, ECOLAB
  • 3:00 pm - 3:15 pm | Afternoon Break
  • 3:15 pm - 3:45 pm | Panel Discussion/Q&A, Speakers
  • 3:45 pm - 4:00 pm | Prizes and Closing Remarks, Chapter President

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

225 Route 202
Basking Ridge, NJ ,

The Grain House