Mark Roberts
Instructor Mark Roberts
Product Id 600527
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Design, Planning and Conducting Effective Audits


Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement.

Proper planning, staffing, training, and implementation are some of the keys to an effective internal audit. Knowledge of the QSR/ISO 13485 is a must along with the auditing standard 19011. In addition to knowing the standards and regulation, effective auditors must also have good communication skills. Audit documentation and follow up is also a key factor. This one hour seminar will provide an overview for establishment of an effective internal audit program.

Why should you attend:
Effective internal quality system audits are critical to improve the quality system and to help prevent observations from the FDA and international regulatory bodies. Proper understanding of the principles and requirements of the related standards is crucial to an effective audit. This seminar will help RA/QA staff understand the basic principles as well as the standards and regulations. This will be useful when planning, performing and documenting internal audits as well as dealing with regulators. It is also beneficial to all of management to learn the requirements so they are prepared as the auditee.

Areas Covered in the Session:

  • Introduction
  • Applicable standards and Regulations
  • Internal vs. External audits
  • Resources
  • Training
  • Planning
  • Audit tools
  • Communication / Listening Skills
  • Audit Documentation
  • Follow Up / Effectiveness
Who Will Benefit:
  • RA Directors, Managers and Staff
  • QA Directors, Managers and Staff
  • Internal audit staff
  • All Management Involved in Internal Audits

Speaker Profile
Mark Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the Western US for TÃœV SÃœD Product Service. He is an accredited lead auditor and notified body auditor. He still performs audits for notified bodies on a contract basis. He has 30 years of experience in the medical device industry. Prior to joining TÃœV he was with Becton Dickinson in their corporate offices as manager of quality systems. He also held various positions in RA/QA, sterility and engineering for Baxter Healthcare. He is a member of AAMI and ASQC Biomedical. Publications include portions of the ASQC Biomedical Quality Auditor Handbook. He has also been an expert witness on quality systems and sterility for the FDA.

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