Quality System
Measurement and Gap Analysis for Pharmaceutical
and Bio-Medical Industries
Interpreting and Applying ICH Q10 Pharmaceutical
Quality Systems Guidance
A Two Day Comprehensive & Interactive Course,
with Workshops and Case Studies On:
- Interpreting and Applying ICH Q10 Pharmaceutical
Quality Systems Guidance
- Comparing cGMP Requirements versus ICH Q10
Guidance
- Essential elements to successfully transition
from cGMP to a Quality System
- Designing and Implementing a Pharmaceutical
Quality System
- Managing the Quality System and Supporting
Processes
- Using Quality Risk Assessment and Risk Management
- Applying a Systems Approach for Assessment
and Measurement
- Conducting a Gap Analysis of Quality Systems
- Developing Effective Quality Policy and Quality
Planning
- Making Decisions Based on Understanding the
Intended Use of a Product
- Tools and Techniques to Review Current Quality
Activities
- Systems for Careful Analysis of Product Quality
- Identifying and Controlling Areas or Weakness
in the System or Process
- Deviation and Investigation Management for
Effective and Timely Remediation
- Maintaining a Well Defined Process and Product
throughout the Product Life Cycle
Interactive Workshop & Group Exercises:
- Comparing cGMP Requirements versus ICH Q10
Guidance
- Contrasting “Old Approach” cGMP
versus “New Approach” Quality Systems
- Identifying clear definition of roles, responsibilities,
authority and accountability for establishing
an effective, efficient and compliant Pharmaceutical
Quality System
- Interpreting and applying systems-based approaches
to manufacturing and distribution of finished
pharmaceutical products.
- Analyzing recent Pharmaceutical Quality System
assessment findings and observations, including
FDA Inspection and Enforcement Trends
Distinguished Course Leaders
Mr. J. Glenn George
Founder and President
QRC Associates LLC
J. Glenn George is the Founder and President
of QRC Associates, LLC, an Integrity-based and
Principle-centered quality, regulatory and compliance
management consultancy. Mr. George as has more
than 30 years of experience in the Life Sciences
ranging from medical technology in healthcare
and hospital environments to the research, development,
technology transfer and commercialization of
products regulated by the United States Food
and Drug Administration and its global counter
parts. He is an accomplished management consultant
and internationally recognized subject matter
expert in all aspects of cGMPs/Quality Systems
and supporting business processes, having managed
comprehensive multinational pharmaceutical,
medical device and biotechnology compliance
management programs throughout Asia, Europe
and North America.
Mr. George has spent the past 16 years rendering
auditing, consulting, training, and technical
services to client companies, specializing in
all facets of quality, regulatory and compliance
management, including integrated management
systems and business process improvements within
the pharmaceutical, medical device, biologic,
biotechnology industries, as well as other non-FDA
regulated industries. He has personally advised,
guided, coached, and mentored client cross-functional
teams, senior management groups, and executive
committees in identifying and achieving strategic,
as well as tactical business, compliance and
quality objectives. Mr. George has also been
an active participant for many years in the
development of various national and international
requirements that govern regulated industries,
including serving as:
• A “Quality System Expert”
to the Consumer Health Products Association
(CHPA) during the development of:
o ICH Q9 Quality Risk Management; and
o ICH Q10 Pharmaceutical Quality Systems.
• A Past Chair of the ASQ Biomedical Division
and Former Chair of the ASQ Biomedical Standards
Committee, participating as an active member
of the U.S. Technical Advisory Group (TAG) to
ISO/TC210 during the development of:
o ISO 13485 Medical devices – Quality
management systems – Requirements for
regulatory purposes; and
o ISO 14971 Medical devices – Application
of risk management to medical devices.
A frequent presenter at FDA/Industry Conferences
and Workshops, his interpretation and practical
application of codes, directives, regulations
and standards has provided considerable guidance
and value to organizations regulated by the
USFDA and its global counter parts.
Dr. Robert C. Menson
President,
Menson & Associates
Dr Robert Menson is President of Menson & Associates, Inc. and has for more than 30 years provided FDA regulated industries with his expertise in quality management systems, risk management/risk assessments, technology assessments, R&D, design control and product transfer. He is an internationally recognized expert in the establishment of systems - based infrastructures and the application of Risk Management Tools and Techniques, supporting organizations in the Pharmaceutical, Biotechnology, and Medical Device industries with modification of their quality and regulatory systems to meet current U.S. and International regulatory requirements.
Dr. Menson has held a number of technical and
management positions with multi-national corporations
throughout the US. He has led and conducted
numerous compliance audits involving governing
requirements of the United States Food and Drug
Administration, as well as their global counter
parts. He has been an active participant on
remedial action teams assisting client organizations
under enforcement action associated with FDA
483s warning letters and consent decrees. He
also served as:
• A “Quality System/Risk Management
Expert” to the Consumer Health Products
Association (CHPA) during the development of:
o ICH Q9 Quality Risk Management; and
o ICH Q10 Pharmaceutical Quality Systems.
As a member of several Industry/Professional
organizations, including AAMI, ISPE, and ASQ,
he is also a frequent presenter at FDA/Industry
Conferences and Workshops.
| Day 1 |
Monday, September
15th, 2008 |
| 8:00 AM - 8:30 AM |
Registration and
Continental Breakfast |
| 8:30 AM - 10:00 AM |
Relationship of
ICH Q10 to Regulatory Approaches to
Pharmaceutical Quality Systems
- Interpretation and application of key
concepts and elements of a Pharmaceutical
Quality System and how they correlate with
a cGMP regulatory requirements.
Particular emphasis will be placed understanding:
- Objectives
- Enablers
- Design and Content Considerations
- Quality System Documentation
- Regulatory approaches used to assess
specific product(s) or manufacturing facility,
including:
- Level of product and process understanding
- Results of quality risk management
- Effectiveness of the Pharmaceutical
Quality System
|
| 10:00 AM - 10:15 AM |
Mid-Morning Refreshment
Break |
| 10:15 AM - 11:30 AM |
Application of a
System Approach to the Assessment and Management
of a Pharmaceutical Quality System
- Evaluation of the functionality of a
Pharmaceutical Quality System and the significance
of
- Linkages between interrelated subsystems
and processes
- Achieving business, compliance and quality
objectives:
- Management Controls
- Design Controls
- Production and Process Controls
- Packaging and Labeling Controls
- Facility and Equipment Controls
- Laboratory Controls
- Material Controls
- Purchasing Controls
- How to apply “Systems Thinking”
as a value-added assessment tool
Group Exercise:
Attendees will compare the applicability
of cGMP requirements using a systems based
approach to contrast “old” style
versus “new” style organizations
with a Pharmaceutical Quality System. |
| 11:30 PM – 12:30 PM |
Luncheon |
| 12:30 PM - 2:30 PM |
Conducting a GAP
Analysis of Quality Systems- Applying ICH
Q10 and cGMPs/Quality Systems Requirements
Part A: Management Responsibilities:
- Assessment of activities and practices
for organizational leadership
- Establishing and maintaining a company-wide
commitment to quality and for the performance
of the Pharmaceutical Quality System
- Objective evidence and the assessment
of management responsibility as it relates
to:
- Management Commitment
- Quality Policy
- Quality Planning
- Resource Management
- Internal Communication
- Management Review
- Oversight of Outsourced Activities
- Establishing clear definition and alignment
of roles, responsibilities, authority and
accountability for the design, implementation
and management of Pharmaceutical Quality
System and the supporting processes.
Group Exercise:
Attendees will work to identify “Responsible
Individuals” with the Duty, Power
and Responsibility to detect, correct and
prevent failures to meet specified (product,
process and/or system) requirements.
|
| 2:30 PM - 2:45 PM |
Mid-Afternoon Refreshment
|
| 2:45 PM – 4:15 PM |
Conducting a GAP
Analysis of Quality Systems- Applying ICH
Q10 and cGMPs/Quality Systems Requirements
Part B: Resources
- Assessment of activities and practices
relating to the allocation of resources
- Developing and sustaining a compliant
Pharmaceutical Quality System and supporting
operational activities
- Objective evidence and the assessment
of resources as it relates to:
- Development of Personnel, taking into
account:
- Identification of training needs
- Planning and execution to satisfy
training needs
- Verification of training effectiveness
- Facilities and Equipment Requirements
- Evaluation, Qualification and Control
Outsourced Operations
- Management’s role determining and
providing adequate and appropriate resources
- Human
- Financial
- Materials
- Facilities
- Equipment
Case Study Discussion:
Analyzing recent Pharmaceutical Quality
System assessment findings and observations,
including FDA Inspection and Enforcement
Trends |
| 4:15 PM - 4:30 PM |
Questions and Answers |
| Day 2 |
Tuesday, September
16th, 2008 |
| 8:00 AM - 8:30 AM |
Continental Breakfast
|
| 8:30 AM - 10:00 AM |
Conducting a GAP
Analysis of Quality Systems- Applying ICH
Q10 and cGMPs/Quality Systems Requirements
Part C: Manufacturing
- Activities and practices relating to
the elements of a Pharmaceutical Quality
System that govern manufacturing operations
and need to be assessed for compliance
- Objective evidence and the assessment
of manufacturing as it relates to:
- Designing, developing and documenting
product, process and system
- Examining inputs (i.e., components,
containers, and closures)
- Performing and monitoring internal
and external operations
- Handling of nonconformities and/or
deviations
- Using a lifecycle approach to the assessment
of a Pharmaceutical Quality System
- Focusing on the activities and practices
associated with:
- Pharmaceutical Development
- Technology Transfer
- Manufacturing
- Product Discontinuation
|
| 10:00 AM - 10:15 AM |
Mid-Morning Refreshment
Break |
| 10:15 AM - 11:30 AM |
Conducting a GAP
Analysis of Quality Systems- Applying ICH
Q10 and cGMPs/Quality Systems Requirements
Part D: Pharmaceutical Quality System
Elements
- Examining activities and practices relating
to Pharmaceutical Quality System requirements
that govern manufacturing operations
- monitoring systems and process performance,
with a desired outcome of ensuring product
quality while operating in a state of control
Group Exercise:
Attendees will work through interpreting
and applying systems-based approaches to
manufacturing and distribution of finished
pharmaceutical products. Representative
situations will be discussed. |
| 12:00 PM - 1:00 PM |
Luncheon |
| 12:30 PM – 2:00 PM |
Conducting a GAP
Analysis of Quality Systems- Applying ICH
Q10 and cGMPs/Quality Systems Requirements
Part E: Evaluation Activities
- Assessing activities and practices to
measure, analyze and continuously improve
the performance of a Pharmaceutical Quality
System
- Objective evidence and the assessment
of manufacturing as it relates to:
- Measurement of the achievement of pharmaceutical
quality system objectives
- Assessment of key performance indicators
- Monitoring of critical success factors,
such as:
- Emerging regulations, guidance and
quality issues
- Innovations or enhancements of
the quality system
- Changes in business strategies
and objectives
- Outcomes
- Improvements to systems and processes
- Allocation or reallocation of resources
- Qualification and training of personnel
- Revisions to quality policy and
objectives
- Timely and effective communication
of the results of management review,
including the escalation of issues
to senior management
- Assessing the measurement, collection
and validation data,
- Converting to meaningful information
for ensuring conformity with specified quality
system, process and product requirements
- Objective evidence and the assessment
of activities and practices as it relates
to:
- Analyzing data trends involving system
and process performance and product quality
monitoring
- Conducting Internal Audits
- Quality Risk Management
- Corrective and Preventive Actions (CAPA)
resulting from the investigation of:
- Complaints
- Product rejections
- Non-conformances
- Recalls
- Deviations
- Audit/Regulatory inspections and
findings
|
| 2:00 PM – 2:15 PM |
Mid-Afternoon
Refreshment |
| 2:15 PM – 3:45 PM |
Case Studies Discussion:
- Review, analysis and discussion of the
application of Useful tools and techniques
– review, analysis and discussion
of application.
Strategies for Successful Planning and
Executing an Assessment of a Pharmaceutical
Quality System:
- Planning and execution of the “Gap
Analysis”
- Importance of collecting and assessing
objective evidence to identify the strengths
and weaknesses
- Special emphasis will be focused on the
assessment of:
- Effective and efficient implementation
of systems and processes
- Opportunities for continual improvement
- Capability of systems and processes
- Use of information technology
- Effective and efficient use of resources
- Product, process and system performance
results and expectations
- Adequacy and accuracy of performance
measurement
|
| 3:45 PM – 4:00 PM |
Conclusion of Program |
Who Should Attend?
This program is designed for Directors, Managers,
and Supervisors in the Pharmaceutical, Biopharmaceutical,
Medical Device, and allied industries with responsibilities
involving the following areas:
- Quality Assurance
- Quality Control
- Compliance Auditing
- Regulatory Affairs
- Product Development
- Project Management
- Manufacturing and Plant Operations
- Change Management
- Validation
- Documentation and Technical Writing
- Marketing
- Sector/Business Units
- Data Control
- Training
- Contract Services
Registration Information:
Registration Fee: $850.00 +
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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