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
• What makes a Good Audit

Course Description

To add value to the business rather than drain resources, your auditing programs must contribute demonstrably to continuous improvement. The key to effevtive 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. Peter Miller Senior Partner Dynamic Compliance Solutions

Mr. Miller, a Senior Partner with Dynamic Compliance Solutions, Inc., has implemented numerous Quality Systems & Audit Programs in Small, Medium and Large scale Pharmaceutical and Medical Device organizations. Over the past 21 years, He has successfully structured audit programs for maximum efficiency and benefit to the owner organizations. By working with the Parenteral Drug Association (PDA) Audit Guidance Advisory Board over the past two years, Mr. Miller has been selected by the PDA to chair the new Standard Audit Criteria Task Force. He has extensive experience in the implementation of cost effective Quality Systems for small, medium & large scale Pharmaceutical and Biotech companies.

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Mr. Daniel S. Whelan CQA, CQ Manager Principal Consultant

Mr. Whelan has more than 30 years experience in manufacturing and quality assurance, working for leaders in their respective fields such as Polaroid, Orion Research and Pfizer Hospital Products Group.

Since 1993, Dan has consulted in the medical device industry and elsewhere as Principal Consultant at Quality Assessment Services, a quality management consulting firm based in Plymouth, Massachusetts. Global assignments include work in Central & South America, and in Europe. He has been a featured speaker and presenter at local society meetings, regional and national conferences, and New England area colleges. He has also conducted public seminars and client training in a number of subjects, including: Quality Auditing, international quality management standards ISO 13485 and ISO 9000, and the US DHHS FDA's Good Manufacturing Practices for Medical Devices. The QA Services client list includes prominent medical device manufacturers such as SynCardia Systems, Inc; Arrow International; Boston Scientific Corp.; Ethicon Inc. and Ethicon Endosurgery; Smiths Medical; GE Sensing, Third Wave Technologies, Inc. and Accellent Inc., among others.

Mr. Whelan was an elected officer of the American Society for Quality’s (ASQ) Biomedical Division when appointed to ASQ's Board of Directors in December 2004. He is a Past Chair of the Boston chapter of ASQ, and was the 1999 recipient of the Boston Society Award, a nationally recognized prize for distinguished achievements in the quality profession. He is currently serving as Chair of ASQ’s Biomedical Division and Ethics Committee. He is an ASQ Senior Member, and holds a number of professional certifications, including ASQ's Certified Quality Auditor and Manager of Quality/Organizational Excellence.

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Mr. Anthony (Tony) Pavel Partner K&L Gates

Anthony (Tony) Pavel is a Partner in the Food and Drug Practice of K&L Gates LLP - a global law firm with over 1800 lawyers, providing regulatory counseling to clients on food, drug, cosmetic and medical device products. Tony has a broad range of experience with issues related to recalls and market withdrawal strategies, auditing and inspections, import detentions, seizures and alleged food tampering. Tony has assisted firms in handling some of the most significant recalls in the U.S. in the last 10 years. In addition, Tony counsels client's with issues related to security measures under the Bioterrorism Act, GMPs, QSRs and GRAS self-affirmations and notifications. Additional areas of his work include product claims in labeling, advertising, and other promotional material, as well as clinical research and substantiation issues, and the National Organic Program. During Tony's undergraduate and legal studies, he worked for a HACCP consulting business.

Day 1 Wednesday, April 14, 2010
08:00 AM	Registration and Continental Breakfast
08:30 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 Similarities and differences in expectations and standard 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 Regulatory Concerns During Auditing Quality system Facilities and equipment system Materials system Production system Packaging and labeling system Laboratory Control System Case Studies: How the Parenteral Drug Association (PDA) is advancing the Standardization of GMP Audits. Warning Letters
10:15 AM	Mid-Morning Refreshment Break
10:30 AM	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: Title has not been given as of yet Auditing Biopharmaceutical Facilities Auditing Sterile Facilities
12:00 PM	Luncheon
01:15 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
02:45 PM	Mid-Afternoon Refreshment
03:00 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 Closing Meeting and Formal Reports Case Studies: How two companies set up audit programs using standard audits & an outsource model
04:45 PM	Questions & Answers
05:00 PM	Conclusion of Day One
Day 2 Thursday, April 15, 2010
08:00 AM	Continental Breakfast
08:30 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	Mid-Morning Refreshment Break
10:30 AM	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 What makes a Good Audit - Will Your Audit Withstand the Scrutiny of Federal Regulators such as the US FDA and CFIA? – Documentation and Process Issues from a Legal-Regulatory Perspective Audit objectivity from the regulator's perspective Documentation from a regulator's perspective
11:15 AM	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 identify critical issues
12:00 PM	Luncheon
01:00 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
03:00 PM	Question & Answer
03:15 PM	Conclusion of the 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

 

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.

Wyndham Montreal Aeroport (Formerly Hôtel Montréal Aéroport) 12505 Cote de Liesse Dorval, Canada H9P 1B7 Tel: +1-514-631-2411 Fax: +1-514-631-0192
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