The Essentials of Complaint Handling and Post Market Management – How to Comply with Global Regulatory Requirements | Jan. 28, 2014, 2-3:30 PM EDT | Rodriguez

Part I: Analyzing the Definition of a Complaint in 21 CFR 820.198

According to the FDA, a complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. This presentation will review the definition of a complaint and will outline an effective complaint handling system.

• Learn how to evaluate a complaint to determine if an MDR or a Recall is required
•   Determine if an investigation is necessary — what are the requirements for designated units and designated investigators?
•   What are the key issues related to Post Market

Part II:Servicing Can Lead to Complaints — an In-Depth Look at 21 CFR 820.200

The FDA cites the quality system regulations 21 CFR 820.200 in warning letters that connect service reports to what they consider unreported complaints. The regulations require that medical device manufacturers must create and maintain records each time they service a device. This presentation will review statistical techniques that can be used to analyze service reports.

• Learn how individual service reports can lead to complaints and MDR’s
• What service personnel should be looking for to identify product complaints when they interact with consumers

Part III:Front Line Employees — Recognizing Customer Interactions as Complaints

The FDA expects firms to train all of their employees to recognize and report product complaints. In two recent warning letters, the FDA cited a company for their failure to train their front line employees on product complaint reporting. This presentation will define steps companies should take to make sure their sales and service people recognize potential complaint and MDR events and report them correctly.
Attendees will:

• Learn how to train the sales force and other customer-facing employees to recognize and report complaints
•  Establish guidelines for customer service representatives to be able to handle complaints

About The Speaker:

Jacquline Rodriguez is President of Monarch Quality Systems. Ms. Rodriguez has over 30 years’ experience in all facets of Quality Assurance and Regulatory Compliance and is currently the President of Monarch Quality Systems Solutions, a consulting firm in New Jersey. Ms. Rodriquez specializes in U.S. Regulations and International, which define Quality Systems and Systems-based Implementation & Auditing (FDA’s QSR/GMPs) 21 CFR Parts 210 & 211, 600, Part 820 and Part 11, ISO 9001/2000, 13485/2003, MDD/IMDD requirements, Canadian Regulation requirements for Medical Device, Pharmaceutical and Biologics Industry, Investigations and CAPA, Process Validation, Document Control, Supplier Quality Assurance systems implementation, Quality Engineering, Risk Management/hazard analysis.As a result, have created and implemented entire Quality Systems for several Pharmaceutical, Biologics and Device companies. Ms. Rodriguez also has extensive knowledge of Compliance- Inspections, Facilitating responses to address FDA-483s and Warning Letters, Electronic Records/Electronic Signatures and Documentation Systems, as well as HIPAA requirements, as well as Lean Manufacturing and Six-
sigma.

Ms. Rodriguez has performed internal clinical audits of ongoing clinical trials in progress across the organization (for both US and EU trials). As well as, completed an objective assessment of where the client’s clinical trials documentation was in with respect to processes and systems and compliance to both US FDA and EMEA, ISO14155 (2011) requirements in order to provide and address any gaps, and remediation task in order to address 483 and warning letters.