Effective Response
to Process Deviations and Failures Investigations
Strategies for Effective Investigations and
Reporting
A One & Half Day Comprehensive & Interactive
Workshop, with Interactive Discussions, Case Studies,
and Workshop On:
- Rules, Regulatory Expectations and International
Requirements for Process Failures and Deviations
- Defining the Level of Risk and Impact Assessment
of Failure
- Strategies for Problem Identification and
Problem Solving Approaches
- Identifying Sources of Non-Conformance and
quality improvement data
- Tracking and Eliminating Non-Conformances
and Deviations
- Manufacturing Process Deviations that warrant
investigation
- Essential Steps of a Thorough Failure Investigation
- Reporting Major and Minor Non-Conformances
- Problem Solving Approaches and Failure Analysis
- Conducting an Effective Root Cause Analysis
(RCA)
- Statistical Tools and Trending Non-Conformance
Data
- Thorough Reporting of Failure Investigations
and Process Deviations
- Obtaining Approval of an Investigation Report
- Documenting a Close-Out and Validating CAPA
- Auditing the Failure or Process Deviation
Investigation
- Handling OOS results and Laboratory Failures
- Developing SOPs for Reporting and Addressing
Process Deviations
Distinguished Course Leaders
David R. Dills
Consultant
Mr. David R. Dills has more than 19 years of
hands-on experience in the FDA-regulated industry,
with emphasis on Class I, II, III medical device
and pharmaceutical/biologics operations in the
areas of regulatory affairs, compliance, software
and process-related validation, quality engineering
and quality systems to ensure compliance with
FDA and international regulations. Mr. Dills
also served as Director of Publications, Regulatory
& Compliance for the Institute of Validation
Technology. He provides contracted services
in the areas of regulatory affairs, including
submissions to the Agency, including IDE/PMA/NDA
and CMC, auditing, internal assessments, compliance,
quality system regulation (QSR), GXP compliance,
CE Mark activities, MDD 93/42/EEC compliance,
ISO 13485/ISO 14971, Risk Management, Inspection
Readiness Preparedness and Training, Agency
enforcement action activities as necessary and
other prescribed quality related services and
consultation on behalf of medical device, pharmaceutical,
and biologics/biotech companies
 Mr.
Eugene. B. Johnston, CQE/CQA Head, North Carolina Office
Biologics Consulting Group,
Inc.
Eugene has over 30 years of experience in FDA-regulated
industries, including Quality Assurance, Quality
Control and Validation. He was most recently
the Vice President of Quality Assurance and
Regulatory Affairs at Biolex, a biopharmaceutical
company involved in the development and production
of therapeutic proteins. Responsible for establishing
the Quality Assurance, Quality Control and Regulatory
Affairs functions, Eugene also established the
Quality Systems programs for preclinical and
clinical manufacturing operations, as well as
overseeing regulatory operations to provide
support for the filing of clinical trial applications.
Eugene’s previous experience includes
being head of Quality at Biogen's Research Triangle
Park manufacturing plant, where he was responsible
for overseeing all Quality Assurance and Quality
Control activities for the start-up and licensing
of the Avonex® manufacturing facility. In
his position at Biogen, Eugene established and
managed the Quality Assurance and Quality Control
functions, supported plant start-up and validation
activities, and led the PAI preparation efforts
which resulted in FDA and EMEA approval within
33 months from the beginning construction.
Eugene received his B.S. in Biology from the
University of Dayton, and is an ASQ Certified
Quality Engineer and Certified Quality Auditor.
Ms. Michelle Sceppa
Principal
MSceppa Consulting
Pharmaceutical and Biotechnology Consulting
Ms. Sceppa has 23 years of experience in Quality
Assurance and Regulatory Compliance in the Pharmaceutical
Industry.
Ms. Sceppa has implemented and managed Preclinical,
Clinical, and Manufacturing Quality Assurance
Programs for numerous clients. As the lead auditor,
she has conducted and managed more than 300
internal and external vendor audits for Drug
and Biologic firms in the US and Europe. Ms.
Sceppa is the Principal in MSceppa Consulting.
MSceppa Consulting is an establish Consulting
firm and is in its 9th year in the Industry.
Ms. Sceppa is knowledgeable in the details
of compliance with all U.S. Federal Regulations-Good
Laboratory Practice (GLP), Good Clinical Practice
(GCP) and Good Manufacturing Practice (GMP)
for Drugs, Biologics and Medical Devices. Ms.
Sceppa is certified in the Q7A Regulations for
the manufacture of Active Pharmaceutical Ingredients.
Ms. Sceppa is a faculty member of the Parenteral
Drug Associations' (PDA) Training and Research
Institute (PDA-TRI) in Baltimore, Maryland.
Program Agenda and Program Content
| Day 1 |
Thursday, October
9th, 2008 |
| 8:30 AM - 9:00 AM |
Registration and
Continental Breakfast |
| 9:00 AM – 10:15 AM |
Investigation Overview
- Why conduct investigations
- GMP and GxP regulations related to
process failures and process deviations
- FDA requirements
- European requirements
- GMP and documentation issues
- Industry practices for failure investigations
and process deviations
- FDA expectations regarding failures
and process deviations
- What are the inspector’s expectations?
- Reworking and Reprocessing
Investigation Procedure
- Definitions
- Types of Investigations
- Process failures
- Validation failures
- Procedural
- Out-of-specification (OOS)
- Customer Complaints
- Action/Alert Limit Excursions
- Investigation Plans
- Problem Solving Approaches
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM - 12:00 PM |
Procedures for Completing
Failure Investigations and Addressing Deviations
- Failure Analysis – What is the
problem?
- Identifying members of an investigation
team
- Rules for completing failure investigations
and process deviations
- Guidelines for documenting the investigation
- Roles and responsibilities - what must
be documented and by whom
- Review or deviation or incident report
- Creating nonconforming material reports
- Assessing out-of-specification (OOS)
results
- Discussing validation failures
- Addressing change control and traceability
with the reports
- Reviewing change control categories
based on risk level
- What information should be utilized
in different types of investigations
Identifying Sources of Non-Conformance
- Raw material
- In-process
- Final product
- Non-conformance with procedure
- Customer complaints
- Adverse clinical events
Performing Root Cause Analysis
- Defining primary and secondary causes
- Common categories of root causes and
contributing causes
- Perform the step-by-step processes
necessary to make RCA effective
- Trending results
- Review of statistical tools
- Quality Improvement Data
- Define problem solving approaches
- Document fact-based conclusion and
proposing corrective actions
|
| 12:00 PM – 1:15 PM |
Luncheon |
| 1:15 PM – 2:45 PM |
Addressing Deviations
and Process Failures within a CAPA program
- Determining when a CAPA is necessary
- Integration of Root Cause Analysis
- Writing CAPA’s that are both
appropriate and measurable
- Avoiding common pitfalls
What is the Best Solution?
- Recommending and Implementing Corrective
Actions
- Tracking progress and re-evaluating
corrective action effectiveness
- Documenting close-out and validating
appropriateness of corrective action
- Challenges and solutions for improving
the review and approval process
|
| 2:45 PM - 3:00 PM |
Mid-Afternoon Refreshment
|
| 3:00 PM - 4:15 PM |
Incorporating Risk
Management into the Investigation Process
- What is risk?
- Risk Identification
- Risk Analysis (Impact Assessment)
- Risk Evaluation (Assessing effect on
other systems or processes)
- Risk Reduction (Corrective and Preventive
Actions)
- Risk Acceptance
- Risk Communication
|
| 4:15 PM – 4:30 PM |
Questions and Answers |
| 4:30 PM |
Conclusion of Day
One |
| Day 2 |
Friday, October 10th,
2008 |
| 8:30 AM - 9:00 AM |
Continental Breakfast
|
| 9:00 AM – 10:30 AM |
Auditing the Failure
or Process Deviation Investigation
Part C: Manufacturing
- Review key elements of the audit process
- Discuss how to correct audit observations
for incomplete reports
- Examine the steps necessary to ensure
completion of various types of investigations
- Discuss various tracking systems to
ensure proper follow-up
- Ensure that SOPs and work instructions
are updated to reflect any changes
- Obtain timely approval of the investigation
report
- Anticipating and avoiding common barriers
and obstacles
|
| 10:30 AM - 10:45 AM |
Mid-Morning Refreshment
Break |
| 10:45 AM – 11:45 AM |
Handling Manufacturing
Process Deviations and Analysis
- Strategies to effectively manage process
deviation investigations
- Planning the investigation
- Conducting the investigation - where
to start and what direction to take
- How to handle change of investigation
direction as investigation continues
- Result evaluation and analysis
- What warrants an investigation?
- Discussion of examples
- Common challenges
- Case Study Discussion
Interactive Discussion and Activity:
Real world examples of process deviation investigations
Attendees will work to solve a process
problem, applying problem solving methodology
to use a logical and structured approach.
|
| 12:00 PM - 1:00 PM |
Luncheon |
| 12:45 PM – 2:15 PM |
Handling OOS Results
and Laboratory Failures
- How to appropriately investigate the
OOS problems
- Identification of OOS results
- Trending non-conformance data
Workshop: Writing Reports for Failure
Investigations and Process Deviations
- Developing SOPs for reporting Failure
Investigations and addressing process
deviations
- Outlining what must be documented
- Various documents associated with an
investigation
- Best practice elements of technical
writing
- Assessing technical content and the
level of detail
Interactive activity
|
| 2:15 PM – 2:30 PM |
Questions and Answers
(Conclusion of Program) |
Who Should Attend?
This one and half day course is directed toward
Managers, Supervisors, Specialists, and Associates
in the Pharmaceutical and Biopharmaceutical and
allied industries with daily responsibilities
in the following areas:
- Quality Assurance
- Quality Control
- Change Control
- Auditing
- Manufacturing
- Compliance
- Production
- Quality Systems
- Documentation
- Validation Engineers/Scientists
- Quality Systems Analysts
- Stability
- Product Surveillance
Registration Information:
Registration Fee: $865.00 +
GST
Online Registration
Payment Information
Hotel Accommodations
Course Location:
AAPS
200 Consumers Road, Suite 200
North York, Ontario
M2J 4R4 Canada
Map
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 $210.00 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
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