Complaints and Recalls | Complaint Handling System in Boston 2018

Start Date : January 25, 2018
End Date : January 26, 2018
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : john.robinson@globalcompliancepanel.com

Location :
Embassy Suites Boston Logan Airport 207 Porter St, Boston, MA 02128, USA

Website

Description







Course "Complaint and Recall Management: A Compliant, Lean Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


 


Overview:


 


Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Attention will be paid to the application of risk management to a complaint handling system, and a specific risk management system explained.


 


Learning Objectives:


 


This seminar contains a streamlined review of the regulations, allowing the majority of time to be spent on a detailed focus on critical process requirements for compliance with the regulations. Jeff will also call from his 30+ years of experience in this area to put forth recommendations for methods of documentation that are straightforward and compliant. Among these recommendations are contents of complaint records, root cause investigations, and corrective actions. This seminar also covers the application of risk management principles to complaint investigation


 


Why you should attend:


 


Complaint Handling is one of the more cross-functional aspects of your QMS, not to mention it being clearly the most customer-facing. To that end, many different functions will benefit from this presentation:



 


Agenda:


 


Day 1 Schedule


 


Lecture 1:


Introductio


Lecture 2:


Complaint Handling



 


Day 2 Schedule


 


Lecture 1:


Adverse Event Reporting



Lecture 2:


Recalls / Field Corrective Actions



Lecture 3:


Q&A - Conclusion


 


 


Speaker


Jeff Kasoff


Director of Regulatory Affairs, Life-Tech, Inc 



Jeff Kasoff, RAC, CMQ/OE, LBB is the Principal Consultant at Lean to Quality, LLC. He has more than 30 years of experience in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.


Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies.


Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.


 


 


 


 Location: Boston, MADate:  January 25th & 26th, 2018 and Time: 9:00 AM to 6:00 PM


Venue: Embassy Suites Boston Logan Airport   207 Porter St, Boston, MA 02128, USA


 


Price:


 


Price: $1,295.00 (Seminar Fee for One Delegate)


Register now and save $200. (Early Bird)


Until December 10, Early Bird Price: $1,295.00 From December 11 to January 23, Regular Price: $1,495.00


Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*


Register for 10 attendees   Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*


 


Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar


At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.


As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.


For More Information- https://www.globalcompliancepanel.com/control/sponsorship 


 




Normal
0




false
false
false

EN-US
X-NONE
X-NONE





















































































































































































































































































































































































































/* Style Definitions */
table.MsoNormalTable
{mso-style-name:"Table Normal";
mso-tstyle-rowband-size:0;
mso-tstyle-colband-size:0;
mso-style-noshow:yes;
mso-style-priority:99;
mso-style-parent:"";
mso-padding-alt:0in 5.4pt 0in 5.4pt;
mso-para-margin-top:0in;
mso-para-margin-right:0in;
mso-para-margin-bottom:6.0pt;
mso-para-margin-left:0in;
line-height:110%;
mso-pagination:widow-orphan;
font-size:10.0pt;
font-family:"Calibri",sans-serif;
mso-ascii-font-family:Calibri;
mso-ascii-theme-font:minor-latin;
mso-hansi-font-family:Calibri;
mso-hansi-theme-font:minor-latin;}

Registration Info

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901339SEMINAR?meetings4docs-January-2018-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous DBA as GlobalCompliancePanel ,
NetZealous LLC-GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA

Tel: Event Manager
Mobile: 800-447-9407
Email: john.robinson@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com/


Event Categories: Cardiology, Critical Care, Dermatology, Emergency Medicine, Endocrinology, Gastro- enterology, General Surgery, Geriatrics, Headache / Migraine, Health & Nutrition, Hematology, Immunology, Infectious Disease, Internal Medicine, Nephrology, Neurology, Obstetrics, Oncology, Ophthalmology, Orthopedic Surgery, Osteopathy, Otolaryngology, Pain Management, Pediatrics, Physical Medicine, Plastic Surgery, Psychiatry, Rheumatology, and Sports Medicine.




Your Review

You must be logged in to post a comment.