Thursday September 2, 2010
GMP Chapter
Effective Quality Assurance Auditing
Identify opportunities to improve your internal audit activity's ability to add value and improve operations - and develop actions to move forward on the path to quality
September 17-18, 2009 | New Jersey, USA

This two-day "hands on" training course & workshops will address various topics, techniques, tools and methods for auditing including:
  • Audit Standards
  • Auditing to U.S. drug (21CFR Part 210/211) and device (21CFR Part 820) good manufacturing practices and the QSR
  • Auditing to European Union directives
  • Auditing to ISO Standards
  • Role Characteristics of the Auditor
  • Auditing Techniques
  • The Audit Process
  • Audit Mechanics
  • Requirements of the Standard Being Audited
  • Internal Facility Audits
  • External Audits
  • Product, process, procedural and system audits
  • Auditing Packaging and labeling system
  • Auditing Laboratory Control System
  • Evaluate Audit Results
  • Preparing Audit Reports results

Course Description

To add value to the business rather than drain resources, your auditing programs must contribute demonstrably to continuous improvement. The key to effective internal auditing and auditing of suppliers is the training of both auditors and auditees in the purpose and relevant techniques of the audit and how these techniques can achieve business benefits.

This two day course and workshops focuses on developing the full set of auditor skills required. Participants will learn about the key techniques and thought processes which may be used by auditors to maximize the benefits of each type of audit.

The course is divided into the following elements: understanding the requirements of the standard being audited, planning effective audits, preparing for the audit, audit team, structuring the audit, conducting the audit, evaluating audits results, reporting audit results, audit follow-ups.


Mr. Luis “Louie” Maldonado
Lead eCompliance & Process Automation Auditor
Novartis – CIBA VISION

Luis “Louie” Maldonado is a Lead eCompliance & Process Automation Auditor. He joined Novartis – CIBA VISION in 2004.

Louie has more than 30 years experience in quality management. Louie has developed a broad diverse background and worked in various regulatory industries and sectors to include pharmaceutical, medical device, aeronautical, insurance, finance, telecommunications, and the US Government. Louie has conducted audits and training in over 21 countries and 32 cities.

Prior to working at Novartis – CIBA VISION, Louie served as an US Army Maintenance Test Pilot, worked with the Army Audit Agency, Government Accounting Office, RAND Corporation, and with new systems/product development. In the private sector, Louie has worked with Accenture, Raytheon, AT&T, Spherion Technical Architects, eLaunchpad, and UCB Pharmaceutical.

Louie has Bachelor of Science in Aeronautics, Bachelor Business Administration in Computer Information Systems, and Master of Science in Adult Education. Louie is an ISO Lead Auditor, CQA and CISA.

Mr. Angelo Scangas
President
Quality Support Group, QSG

M.B.A. – University of Massachusetts 1995

M.S. MANUFACTURING ENGINEERING – University of Massachusetts 1985

B.S. CHEMICAL ENGINEERING – Worcester Polytechnic Institute 1980

American Society for Quality: Member, Certified Six Sigma Black Belt, Certified Quality Engineer, RABQSA Certified Lead Auditor for ISO 9001, SQF (Safe, Quality, Food) Experience, HACCP Auditor, ISO 13485 Consulting and Training experience, 21CFR820 experience

Angelo has more than 30 years experience in the Medical Device, Automotive, Consumer, Electronic, Healthcare and Chemical Industries working in development/manufacturing engineering, quality engineering, quality assurance and process improvement (Lean and Six Sigma) His background includes test design engineering, supplier quality, (ISO 9001, ISO 14001, ISO 13485, ISO 13408, TS 16949) quality system design and implementation, quality field evaluation, regulatory negotiations, internal and external audits and FDA submittals. His specialty areas include document control systems, corrective and preventive action (CAPA) programs, FDA QSIT regulatory conformance for devices, validation programs, third-party assessments and HACCP analysis.

Mr. Michael Gregor
Chief Executive Officer
Compliance Gurus Inc.

Michael J. Gregor is the Chief Executive Officer of Compliance Gurus Inc., a premier compliance consulting and software solution provider. Prior to forming his own company, Michael acquired over 20 years of experience in the FDA regulated industry. His areas of compliance expertise include: Biological, OTC and Pharmaceutical drugs, Cosmetics, Dietary Supplements, Foods, and Medical Devices.

Mr. Gregor has distinguished himself as an industry authority. He has provided compliance guidance to several Fortune 500 companies, which include Pfizer, Schering-Plough, Monsanto, Wyeth and Boston Scientific. In addition, Mr. Gregor has authored several published articles and white papers concerning GCP, GLP and GMP issues. He holds a B.S. in Business Management, from National Louis University and a dual Master Degree in Business Administration and Information Systems Management, from DeVry University. Michael frequently lectures on compliance topics at industry conferences and events throughout the year.

Day 1 - Thursday, September 17th, 2009
8:00 AM - 8:30 AM - Registration and Continental Breakfast
8:30 AM - 10:15 AM - Why are Audits so Important?

Audits are used to determine the extent to which the management system requirements are matched. It is the auditors‘ duty to determine whether the audit criteria are fulfilled. This requires a good cooperation with the auditee. Cooperation is based on communication. For auditors communication means steering the conversation using questioning and interview techniques that enable a free exchange of information.

Audit Standards

  • Auditing to U.S. drug (21CFR Part 210/211) and device (21CFR Part 820) good manufacturing practices and the QSR
  • Auditing to European Union directives
  • Auditing to ISO Standards
  • Similarities and differences in expectations and standard

Regulatory Concerns During Auditing

  • Quality system
  • Facilities and equipment system
  • Materials system
  • Production system
  • Packaging and labeling system
  • Laboratory Control System

Case Studies:

  • Warning Letters
10:15 AM - 10:30 AM - Mid-Morning Refreshment Break
10:30 AM - 12:00 PM - Auditing Basics
  • Reasons for audits and audit models (overview)
  • The Purpose of Audits
  • Role Characteristics of the Auditor
  • General Themes for All Audits

Audit Types, Classification & Methods

  • Internal facility audits
    • Product, process, procedural and system audits
    • External Audits
    • Supplier/contract manufacturer audits
    •  Team audits
  • Similarities and differences in audit types
  • Being audited
    • Customer audits
    • Regulatory agency audits
  • Audit Techniques
  • Audit Planning

Case Studies: 

  • Auditing Biopharmaceutical Facilities
  • Auditing Sterile Facilities
12:00 PM - 1:15 PM - Luncheon
1:15 PM - 2:45 PM - The Audit Process
  • Audit scheduling
  • Conducting the audit
  • Managing the Audit Team
  • The Exit Meeting
  • Audit Reporting
  • Audit closing meeting and measuring success
  • Lead auditor’s tasks and behavior in the closing meeting

Audit Mechanics

  • Preparation, Performance & Conclusion
  • The importance of documentation
  • Audit reports and audit follow-up
  • Effecting change
  • The pluses and minuses of "surprise audits”
  • “How to" and "how not to" perform audits
  • Strategies and techniques to maximize audit effectiveness
  • Listening & observation skills
2:45 PM - 3:00 PM - Mid-Afternoon Refreshment
3:00 PM - 4:45 PM - Auditing Contract Laboratories
  • Reviewing the essentials of compliance auditing
  • Preparing the audit plan, audit team, and communications Performing a pre-audit assessment
  • Examining various approaches and issues in auditing
  • Checklists
  • Interviewing techniques
  • Review of SOPs and records
  • Determining what to include in the audit report
    • Internally
    • Externally
  • Closing Meeting and Formal Reports

Case Studies:

  • Recent 483 issues applicable to the above systems
4:45 PM - 5:00 PM - Questions & Answers
5:00 PM - Conclusion of Day 1
Day 2 - Friday, September 18th, 2009
8:00 AM - 8:30 AM - Continental Breakfast
8:30 AM - 10:15 AM - Preparing an Audit Summary Report
  • Forms design
  • Advantages and disadvantages of audit checklists
  • Audit finding categories
  • Grading lists
  • Open-ended report format

Presenting QAAs to Management

  • Communication skills for presentation of audit findings
  • Obtaining response and action on audit findings
  • Global management strategies

Audit Response and Follow-up Audits

10:15 AM - 10:30 AM - Mid-Morning Break
10:30 AM - 12:00 PM - What Makes a Good Audit?
  • Audit objectivity
  • Auditing standards
  • Auditor qualifications; auditor training
  • Creating a win-win audit - turning the audit into a positive coaching experience for yourself, your company, and those you are auditing
  • Do’s and don‘ts of the audit

Ways to Measure the Success of an Audit - Simple Effectiveness Reviews – how do you know the action plan worked

Importance of Selecting an Audit Team with the Necessary Training and Experiences

Role Characteristics of the Auditor

  • Examination of the phenomenon of verbal and non-verbal communication
  • Analysis of the art of questioning and conversation techniques
  • Development of questioning and interview techniques
  • Awareness of possible conflict situations
  • Formal aspects of the audit scheme
  • Preparation and organization of an audit
  • Conducting the audit
  • Audit documentation
  • Writing the audit report
  • Follow-up activities
  • How to identifying critical issues
12:00 PM - 1:00 PM - Luncheon
1:00 PM - 3:00 PM - WORKSHOP Conducting Internal Audit
  • Process and its important components
  • Planning and preparation activities
  • Essential steps for performing a successful quality audit
  • Gathering objective evidence and the need to remain objective at all times
  • Preparing accurate report and that its supportable by the evidence
  • Identify the correct steps in the processes of corrective action and root cause analysis
  • Identify the importance of audit authority, planning, scheduling, keeping records, maintaining audit independence and upholding audit ethics
  • Identify the audit implications for each clause and sub-clause of the new ISO 9000 standard
3:00 PM - 3:15 PM - Question & Answers
3:15 PM - Conclusion of Program

 

This two day course and workshops is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, and allied industries with responsibilities in the following areas:

  • QA auditors and trainees
  • Regulatory/Compliance
  • Quality Assurance
  • Quality Control Laboratory Compliance
  • Auditing
  • Documentation Management
  • Engineering managers who receive internal QA and corporate GMP audits
  • Production personnel who lead Self Inspection audits
  • API Manufacturing
  • GMP/GLP Compliance
  • Training
  • Documentation and Technical Writing
  • Contract Laboratories
  • Contract manufacturing
  • Plant Management
  • Consultants and government inspectors

Take advantage of this unique opportunity to participate in a shared learning environment and find expert solutions

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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 $250.00 USD per 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.

Crowne Plaza Hotel

SOMERSET-BRIDGEWATER
110 Davidson Ave.
Somerset, NJ 08873
United States

Hotel Front Desk: 001-732-560-0500
Hotel Fax: 001-732-560-3669

A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention International Pharmaceutical Academy to receive the reduced room rate.

For more information, please call us at 416-410-7402 or enquiry@ipacanada.com
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