ComplianceOnline

This 2-day seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.

However, many companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well-planned audit program can reduce these risks.

In this seminar, we will discuss:

  • Regulatory Expectations
  • How to develop and implement an efficient and effective audit program
  • Common problems
  • Red-flags that your program is not effective
  • Risk Analysis techniques
  • Audit Program Structure
  • The auditing process – steps and tools
  • Documentation and communication
  • Linkages within your Quality System to ensure audits lead to effective solutions and lasting improvement

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Using lecture, interactive discussion, and exercises, this seminar will provide tools and techniques for you to develop or improve your audit program. Students will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference. This 2-day seminar will cover the following areas:

  • Using a structured program to identify areas of risk leading to an effective audit strategy.
  • How to develop a meaningful structure of audit, oversight, transparent communication, and escalation to management review.
  • How to ensure your audit staff is well trained to proactively identify, communicate, and escalate issues.
  • How a culture of quality and compliance can encourage clear and transparent communication of risk.
  • How to prioritize, resource, and implement corrective actions.
  • Techniques for monitoring and communicating risk and improvement over time.
  • How to identify residual risk.
  • Signs that your company culture is taking unnecessary compliance or quality risk.
  • How to ensure management gets valuable information from your audit program.
  • Tools for documenting audit observations and managing corrective and preventive actions.
  • Roles and responsibilities.

Why Should You Attend:

Continuous Improvement starts with awareness of issues and opportunities. And without an effective audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This seminar will highlight red-flags and ways to reduce compliance and quality risk.

Who will Benefit:

  • Quality Systems Specialists
  • Document Control Specialists
  • Quality and Compliance Specialists
  • Auditors
  • Internal Auditors
  • Supplier Auditors
  • Auditor Managers
  • Supplier Auditors
  • CAPA Specialists
  • Quality/Compliance managers or directors for Medical Device, Pharmaceutical, or Bio-tech companies
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • Session Start Time: 9:00 AM
  • Overview
  • Introductions
  • Regulatory expectations
  • Quality Systems requirements
  • Types and goals of audits
  • Creating a program
    • Goals
    • Risk Analysis
    • Audit schedule
    • Oversight, communication, monitoring, and escalation
  • Linkages in your Quality System
    • CAPA
    • Metrics and monitoring
    • Management Review
    • What the FDA can look at
    • Record keeping and documentation
  • Auditor qualifications and skills
Day 02(8:30 AM - 4:30 PM)
  • The auditing process
    • Preparation
    • Planning
    • Conducting
    • Interviewing techniques
    • Good documentation
    • Following-up
    • Monitoring progress
  • Focus on Supplier Auditing
  • Red Flags and Warning Signs
  • Best Practices
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Susanne Manz

Susanne Manz,
MBA, MBB, RAC, CQA, President and Principal Consultant, Manz Consulting Inc

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at industry leaders like GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world conducting audits and helping companies to understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.

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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

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Gold Partner
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  • A half page brochure advert
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  • Moving banner ad on the website
Silver Partner
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  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
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  • Logo on name cards
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  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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