2-day In-person Seminar on “Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors” in Australia-2014-09-24

Event details: 
Title: 

2-day In-person Seminar on “Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors” in Australia

Event dates: 
Thursday, September 25, 2014 to Friday, September 26, 2014
Description: 

Detailed Description:
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analysed, and corrective action shall be taken.

Meet your Expert:
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's.

Audience:
Regulatory Affairs Management, Regulatory Affairs Specialist, Auditors, Compliance Officer, Compliance Specialist, Clinical Affairs, Quality Assurance Management, Marketing & Sales, Distributors/Authorized Representatives, Legal Counsel, Engineering/Technical Services, Operations/Manufacturing, Consultants

RAC Credits: 12
Date: September 25th & 26th, 2014
Event Details: http://bit.ly/1yyH8Xl
Location: Sydney, Australia
Venue: Hilton Sydney Hotel, 488 George Street, Sydney, Australia 2000
Venue Website: http://www.hiltonsydney.com.au/
Registration: Open Enrollment
Delivery: Face-to-Face event
Until August 25, Early Bird Price: $1,595.00
From August 26 to September 23, Regular Price: $1,795.00

Objective:
Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system. Determine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority, references and guidance. Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion.

Course Web Site: https://www.globalcompliancepanel.com/control/~product_id=900113SEMINAR
Provider:
GlobalCompliancePanel
John Robinson
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Phone: 800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: www.globalcompliancepanel.com

Organizer:
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management.

Our Achievements:
Over 300 Experts that are Renowned in their Respective Areas
Successfully Trained more than 20,000 Compliance Professionals
A Most Comprehensive Portal for Trainings, Industry Updates and Professional Growth
Having more than 2000 Online Courses
Successfully Completed more than 170 Seminars in US and Globally

Event type: 
Conference
Language: 
English
Event location: 
Hilton Sydney Hotel
488 George Street
Sydney NSW 2000
Australia
Event position: 
Organizer details: 
Contact name: 
John Robinson
Organization: 
GlobalCompliancePanel
Location: 
161 Mission Falls Lane
Suite 216
Fremont, CA 94539
United States
Event information: 
Chemistry techniques: 
Registration deadline: 
Thursday, September 25, 2014
Abstracts deadline: 
Sunday, September 28, 2014
Posters deadline: 
Wednesday, September 17, 2014
Keynote speakers: 

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's.

Registration fees and grants: 

RAC Credits: 12
Date: September 25th & 26th, 2014
Event Details: http://bit.ly/1yyH8Xl
Location: Sydney, Australia
Venue: Hilton Sydney Hotel, 488 George Street, Sydney, Australia 2000
Venue Website: http://www.hiltonsydney.com.au/
Registration: Open Enrollment
Delivery: Face-to-Face event
Until August 25, Early Bird Price: $1,595.00
From August 26 to September 23, Regular Price: $1,795.00

Sponsors: 

Organizer:
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management.

Our Achievements:
Over 300 Experts that are Renowned in their Respective Areas
Successfully Trained more than 20,000 Compliance Professionals
A Most Comprehensive Portal for Trainings, Industry Updates and Professional Growth
Having more than 2000 Online Courses
Successfully Completed more than 170 Seminars in US and Globally