Effective Quality Assurance Auditing
Strategy for Successfully Planning and Performing QA Audits
A Two Day Comprehensive & Interactive Course, with Workshops and Case Studies On:
- Regulatory expectations for FDA, EU, and ISO requirements
- Requirements for Medical Devices, Pharmaceuticals and Biotech Products
- Audit mechanics
- Implementing surprise audits
- Know what is involved with an effective quality assurance audit
- Types of audits and why they are necessary
- Auditor skills, qualifications, and communication skills
- Implementing a global management strategy
- How to prepare your team for an audit
- Strategic performance of an audit
- How to close-out audits
- Distinguishing Minor and Major Observations – Audit rating
- Reporting findings to management
- Decision making based on audit findings
- Audit follow-ups and CAPA programs
- Implementing effective internal audits - Product, process and system audits
- How to get the best out of audits
- Documentation requirements ; forms, check-lists, reports, etc. .
Interactive Workshop Activities
- Developing an effective Quality System Audit Program
- Laboratory Internal Audits - Suspect Test Results and Deviation Documentation
Distinguished Course Leader
Mr. Martin Browning, MS
President
EduQuest, Inc.
Mr. Browning is the President and co-founder of EduQuest. He has over thirty years
of FDA and regulatory experience. He has and demonstrates extensive expertise in
management consulting, FDA regulation, regulatory affairs, quality assurance, software
and systems engineering, and auditing. Specific experiences include quality systems
design, system design assurance, verification and validation of production and medical
systems, processes and software. Mr. Browning is a well-respected expert in FDA
regulations having written or contributed to writing many during his FDA career.
He left the Food and Drug Administration in 1995 after 22 years as a local, national,
and international expert Investigator and then as a Special Assistance to the Associate
Commissioner for Regulatory Affairs. While with FDA, Martin served a Vice Chair
of the Electronic Record and Signature Working Group, which drafted the 21 CFR Part
11 regulations. He also served as Chair of the US Government ISO-9000 committee;
on the Global Hamonization Task Force; and on the committee that developed the new
medical device good manufacturing practice regulations, otherwise known as the Quality
System Regulation (QSR). He participated in the EduQuest Computer System Validation
training courses presented to FDA. Mr. Browning has an undergraduate degree in Aerospace
Engineering snf Political Science and a Masters Degree in Computer Science.
Mr. Thomas Feyerabend
Principal Consulting
PAREXEL Consulting
Thomas Feyerabend has more than 25 years of Quality Management experience in food, pharmaceutical, medical device/diagnostics, and biologics industries. This experience includes testing laboratory management, quality engineering, external (supplier/contractor) and internal regulatory and quality systems auditing, quality systems development and implementation, quality assurance program development and implementation, training, strategic planning, and executive management.
Mr. Feyerabend joined PAREXEL Consulting in
May 2001 after more than 20 years of Quality
Management experience, including Director of
QA/RA for Alpha Therapeutics and Area Director
of QA for the Biomedical Services Division of
The American Red Cross. He also held a range
of quality positions at Marion laboratories
and Marion Merrell Dow related to both pharmaceuticals
and medical device/diagnostic products.
Mr. Feyerabend helps clients achieve exceptional
business performance, sustained regulatory compliance,
and effective risk management through the development,
implementation, and assessment of Quality Programs
and Systems. He has worked with clients in many
capacities including executive on loan (Executive
VP of QA/RA) for major biologics and contract
manufacturing firms.
Tom is a regular speaker on a variety of quality
and regulatory topics for various industry organizations
and conferences. He holds a Masters in Microbiology
from the University of Missouri and a Bachelor
in Biology from William Jewell College.
Mr. Angelo Scangas
President
Quality Support Group, Inc.
Angelo Scangas has assisted numerous clients in the areas of process improvement,
Lean Six Sigma, ISO 9001:2000, ISO 14001, ISO/TS 16949 and ISO 13485 certifications.
He has extensive training experience in internal auditing, advance product quality
planning, FMEA, problem solving, project management, and SPC.
Angelo has worked in the medical devices, biomedical, automotive, textile, chemical,
and electronics industries for more than 30 years, holding positions such as director
of manufacturing, director of quality, and plant manager.
Angelo is a member of the American Society of Quality and AIAG. He is a Certified
AIAG, IAOB and RAB-Lead Auditor. He is also a member in the Quality Management and
Automotive Divisions of ASQ.
Program Agenda
| Day 1 |
Thursday, April 17th, 2008 |
| 8:00 AM - 8:30 AM |
Registration and Continental Breakfast |
|
8:30 AM - 10:15 AM |
Regulatory Expectations and Audit Standards
- Auditing to U.S. drug (21CFR Part 210/211) and device (21CFR Part 820) GMPs and
the QSR
- Auditing to European Union directives
- Auditing to ISO Standards
- Similarities and differences in expectations and standard
Overview of QA’s Role and QA Auditing Roles
The Role of QA within the Organization
- Review of QA methodology and philosophy
- Functioning other departments – manufacturing and operations, purchasing, product
development, production, engineering, and quality control
- Reporting relationship
The Role of the Quality Assurance Audits (QAA)
- Purpose of Quality Assurance Audits
- Audit principles and objectives
- Cost Benefits Analysis: true costs of quality, the costs of product and process
failure
- Politics of auditing
Comparing the Different Types of Audits
- Internal facility audits
- Product, process and system audits
- Auditing of contract manufacturers
- Supplier audits
- Strategies and techniques to maximize audit effectiveness
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment Break |
| 10:30 AM - 12:00 AM |
Performing Audit Procedures
- Preparation steps, Performance and Conclusion
- Importance of documentation
- Listening and Observation skills
- Distinguishing between minor and major observations
- QA Staff Interviews
- Implementing Surprise Audits
- Common challenges when performing an audit
- Audit reports and audit follow-ups
|
| 12:00 PM - 1:15 PM |
Luncheon |
| 1:15 PM - 2:45 PM |
Audit Reporting and Documentation
- Collection, organization, analysis, and reporting of audit data
- Report formats, designs, and templates
- Preparing audit checklists
- Advantages and disadvantages of audit checklists
- Grading lists
- Summary Reports
- Open-ended report format
- Developing and applying the decision process
- Making recommendations for improvements to the QA system
- Maintaining confidentiality of results
|
|
2:45 PM - 3:00 PM |
Mid-Afternoon Refreshment |
| 3:00 PM - 4:30 PM |
Internal Auditing Considerations for Medical Device Manufacturers
- Audit Performance - Opening meeting and facility tour
- On-site activities
- Effecting change
- Audit follow-ups
|
|
4:30 PM - 4:45 PM |
Questions and Answers |
|
4:45 PM |
Conclusion of Day One |
| |
| Day 2 |
Friday, April 18th, 2007 |
| 8:00 AM - 8:30 AM |
Continental Breakfast |
| 8:30 AM - 10:15 AM |
Elements of a Successful and Effective Audit
- How to avoid common mistakes during audits
- Strategies for Maintaining Objectivity
- Utilizing existing resources
- Meeting auditing standards
- Auditor qualifications, skills, and attributes
- Developing the internal audit team
- Ensuring the audit is a positive experience
Presenting QAAs to Management
- Communication skills for presentation of audit findings
- Obtaining response and action on audit findings
- Global management strategies
|
|
10:15 AM - 10:30 AM |
Mid-Morning Refreshment Break |
|
10:30 AM - 12:00 PM |
Interactive Discussion and Case Study Session
Developing an effective Quality System Audit Program
- Construction of an effective audit program
- Strategies for planning, scheduling and administering
- Developing checklists and documentation reviews
|
|
12:00 PM - 1:00 PM |
Luncheon |
|
1:00 PM - 2:30 PM |
Interactive Case Studies and Workshop Session
- Developing an effective Quality System Audit Program
- Conducting Laboratory Internal Audits
- Using Quality Audit Checklists
- Preparation of Audit reports
- Non-Conformance Reports
- Corrective Action logs and reviews
- Potential for Improvement Reports
|
|
2:30 PM - 3:00 PM |
Questions and Answers |
|
3:00 PM |
Conclusion of Program |
| |
Who should attend?
This program is designed for Directors, Managers, Supervisors, Analysts, and Associates
in the Pharmaceutical, Biopharmaceutical, Medical Device, and allied industries
with responsibilities involving the following areas:
- Quality Assurance
- Compliance Auditing
- Regulatory Affairs
- Documentation and Technical Writing
- Quality Control
- Validation
- Laboratories
- Product Development
- Project Management
- Product Submission
- Training
- Manufacturing
- Consultants
- Contract Services
- GXPs
Registration Information:
Registration Fee: $885.00 + GST
Online Registration
Payment Information Course
Location and Hotel Accommodations
Registration Fee Includes:
Presentation Materials, Luncheon and RefreshmentsCancellation/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
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