Date: | April 6, 2017 - 9:00am - April 7, 2017 - 6:00am |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090, Baltimore, MD, 21090, United States |
Website for Event: | http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900762SE... |
Topic: | Health Education |
Description: | Keywords: food and drug administration, FDA inspections, regulatory compliance, clinical research, biologics manufacturing process, pharmaceutical manufacturing, biopharmaceutical manufacturing, Documentation Management, electronic document management FDA Inspections, Pharmaceutical Manufacturing, Regulatory Compliance| Seminars – GlobalCompliancePanel Why is FDA at my facility, and what do I do during an inspection 2017 Course "Why is FDA at my facility, and what do I do during an inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview:Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections. Who will benefit: Agenda: Day 2 Schedule Speaker: David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, post marketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to post marketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk. Location: Baltimore, MD Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM Venue: The DoubleTree Baltimore-BWI AirportAddress: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090 Price: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar Fee for One Delegate) Until February 28, Early Bird Price: $1,295.00 from March 01 to April 04, Regular Price: $1,495.00 Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Quick Contact: Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
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Contact Name: | Event Manager |
Contact Email: | support@globalcompliancepanel.com |
Contact Phone: | 800-447-9407 |