Developing an Effective
Complaint Handling and Recalls Program
A One and Half Day COMPREHENSIVE & INTERACTIVE
Course with Workshops and Discussions ON:
- Definition of complaints and Complaint Handling
pitfalls
- Distinguishing between different types of
complaints
- Post Market Surveillance to improve risk
management
- Regulatory Expectations
- APR ‘s and the CFR Requirements
- International and domestic requirements for
complaints and recall
- Development of Procedures for Managing Complaints
- Setting up a System for Complaints Handling
- Implement and Management of Complaints Handling
System
- Effectiveness of the Complaint Handling System
- Type of Data Required and analysis of results,
ensuing to possible product change
- Managing Recalls and Warning Letters
- Changes required after investigation of non-conformance,
complaint resulting in recall
Distinguished Course Leader
Dr. Richard Pike
Dr. Richard Pike has over thirty years of
experience in the pharmaceutical industry. Most
recently, he served for over ten years as Senior
Vice President of R&D and Regulatory Affairs
at Genpharm, a subsidiary of Merck KGaA, where
he was responsible for overseeing development
of over fifty-five products for submission into
USA, Canada, and European dossiers. Dr. Pike
also worked at Health Canada for many years,
first as a Research Scientist in the Pharmaceutical
Chemistry Division for the Bureau of Drug Research,
and subsequently as Senior Drug Evaluator for
the Therapeautic Programmes Directorate (TPD).
Prior to joining Health Canada, he served as
Director of Clinical Research at Stiefel Laboratories
and Director of the Bio-analytical Laboratories
at Bioresearch Laboratories. He began his career
as a synthetic medicinal chemist. Currently,
he is a consultant to the pharmaceutical industry,
helping companies with their GMP, GCP and GLP
areas and strategies for effective R and D.
Ms. Sandra M. Ireland
Regulatory Affairs Manager
Cubic International
Sandra Ireland received her B.Sc. in Biochemistry and Chemistry from the University of Western Ontario. She also holds a Post Diploma in Pharmaceutical Regulatory Affairs & Quality Operations from Seneca College and a Clinical Research Associate Diploma from the Michener Institute in Toronto. Sandra has 8 years regulatory compliance experience within the drug and device manufacturing environments. She is currently employed at Cubic International as the Regulatory Affairs Manager.
Janice B. Wilson, PhD
Senior Consultant
Biologics Consulting Group, Inc. (BCG)
Dr. Wilson has over 25 years experience in bioscience industries including the development, implementation, and directing of sustainable quality systems, quality assurance programs, and regulatory compliance programs for GMP and ISO activities. Prior to joining BCG, Dr. Wilson held senior quality compliance management positions at Wyeth Pharmaceuticals and most recently at Novartis Vaccine and Diagnostics, in Emeryville, CA. She received her doctorate degree in chemistry from UC Berkeley.
Program Agenda
| Day 1 |
Thursday April 24th,
2008 |
| 8:00 AM - 8:30 AM |
Registration and
Continental Breakfast |
| 8:30 AM - 10:15 AM |
Definition of Complaint
- What is a Compliant
- Distinguishing between different types
of complaint
- Documenting the complaints in compliance
with FDA
- International and domestic requirements
for complaints and recall
Post Market Surveillance(PMS’) and Regulatory
Requirements
- Review of Regulatory, standards and
guide documents
- Review of FDA inspection trend for
(PMS’) requirements on reporting of adverse
drug reactions
- Data usage of previous complaints toward
PMS
APRs and the CFR Requirements
- Function of APR and use and GMP Requirements
- Use of APR in FDA inspections
- Regulatory requirements stated in 21
CFR 211.180(e)
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM - 12.00 PM |
How to Develop Procedures
for Managing Complaints
- Implementing in GMP-System
- Risk management planning
- Self assessment
|
| 12:00 PM - 1:00 PM |
Luncheon |
| 1:00 PM - 2:45 PM |
Implementing and
Managing a Complaints Handling System
- Sample evaluation, Handling and Storage
- Failure investigation
- Type of Data Required and analysis
of results, ensuing to possible product
change
Process of setting up a Complaint Handling
System and How Complaints Become CAPAs
- What are the elements of an effective
CAPA system
- What sources of actual and potential
product and quality data should be analyzed
for CAPA?
- What techniques can you use to detect
recurring quality problems?
- When do complaints become CAPAs?
|
| 2:45 PM - 3:00 PM |
Mid-Afternoon Refreshment |
| 3:00 PM – 4:15 PM |
Workshop: Interactive
Discussion
How Your CAPA System Can Be Used to Support
Your Complaint Management System
- How do both systems rely on similar
records, timeliness, trending across multiple
sources, management review and closure?
- How do the results of complaint trends
influence the CAPA system?
- What role does the preventive part
of CAPA play in your complaint management
system?
- How can CAPA be used to predict complaint
trends and establish organizational performance
metrics?
- Where do servicing and repair fit into
CAPA and Complaints?
- How can the systems work together to
ensure that you have safe and effective
products?
|
| 4:15 PM - 4:30 PM |
Questions and Answers
|
| 4:30 PM |
Conclusion of Day
One |
|
|
| Day 2 |
Friday April 25th,
2008 |
| 8:00 AM - 8:30 AM |
Continental Breakfast |
| 8:30 AM - 10:00 AM |
Returns and Salvaging
According to Subpart K,
- CFR 211.204 Returned Drug products.
- CFR 211.208 Drub product Salvage
Recalls
- Classification of recalls
- Changes required after investigation of non-conformance, Complaint resulting in recall
|
| 10:00 AM - 10:15 AM |
Mid-Morning Refreshment
Break |
| 10:15 AM - 11:45 AM |
Managing Recalls
- Personnel involved in evaluating the
information
- Initiating a Recall and Informing the
Right People
- How the recalled material should be
treated
Effectiveness of the Complaint Handling System
- Reasons to maintain a complaint and recall system
- International requirements
- Source of the information
- Selection, analysis of information
|
| 11:45 AM - 1:00 PM |
Luncheon |
| 1:00 PM - 2:15 PM |
Case Study Discussions
and Workshop:
Examples of different cases of complaints
resulting in failure, non-conformance and
recall
You will learn how to determine the scope
of validation measures by means of risk
assessment and investigate a complaint of
a product, develop an action plan and decide
what to do with the product. |
| 2:15 PM - 2:30 PM |
Final Questions and
Answers - Conclusion of Program |
Who Should Attend?
This one and half day program is directed toward
Managers, Supervisors, Analysts, and Associates
in the Pharmaceutical, Biopharmaceutical, Biotech,
and allied industries with daily responsibilities
in the following areas:
- Regulatory Affairs professionals
- Quality Assurance managers
- Quality Control managers
- Engineers and Engineering managers
- Quality Engineers
- Product Developers
- Medical Devices
- Chemistry, Manufacturing and Controls (CMC)
- GMP/GLP Compliance
- Training
- Documentation and Technical Writing
- Consultants
- Contract manufacturing
and other Compliance professionals
Registration Information:
Registration Fee: $850.00 +
GST
Online Registration
Payment Information Course
Location and Hotel Accommodations
Registration
Fee Includes:
Presentation Materials, Luncheon, and Refreshments
Cancellation/Substitutions
Policy:
CANCELLATION POLICY:
Cancellation is accepted in writing (by mail,
or fax) up to 4 weeks before the program start
date, after which cancellations are not accepted
and do not qualify for refund or credit. All Cancellations
are subject to a $212.00 CAD (incl. GST)/person
processing fee. Substitution of delegate/s with
the member/s of the same organization is permitted
at any time. IPA reserves the right to postpone
an event, prior to which time all the registered
attendees will be notified a minimum of 2 weeks
in advance. IPA shall not be responsible for any
air fare, hotel or transportation costs incurred
by registrant/s.
Certificate of Attendance:
All participants will receive a certificate of attendance
upon completion of the course
For registration or any further
information, please contact us at:
Tel: (416) 410-7402
Fax: (416) 491-5810
|
