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2-day Hands-On Workshop: Writing Exceptional Audit Report

November 10 @ 8:30 am - November 11 @ 5:00 pm

Friday, November 10 and Saturday, November 11, 2017 (8:30am to 5pm each day)

You have conducted a thorough quality system audit:  you observed processes, reviewed procedures and records, and interviewed personnel.  How do you communicate the results to gain the maximum benefit?  By writing a clear, concise audit report.

Ineffective audit reports:

  • Inhibit continuous improvement of the evaluated systems,
  • Lead to confusion about requirements, and
  • Waste time addressing insignificant issues.

Exceptional audit reports:

  • Communicate gaps in compliance to the audit sponsor, and
  • Facilitate the auditee’s response to gaps in compliance, identifying appropriate corrections, corrective actions, and/or preventive actions.

Attendees will work in teams to identify the crucial elements of an exceptional audit report, review examples of poorly written observations, and practice writing unambiguous observations (gaps in compliance) to maximize the usefulness of the audit report to the organization.  A workbook and electronic templates will be provided.

Most examples used in the workshop are from ISO 9001 or pharmaceutical/medical device good manufacturing practices (quality system) audits, but principles presented apply to reports for a quality audit from any type of industry or organization.

 BONUS:  Regulatory authorities around the globe are focusing on data integrity during their inspections of pharmaceutical companies.  Quality auditors can help their organizations reduce risk by ensuring that data integrity issues are identified and product quality is protected.  Data integrity auditing principles will be reviewed, and data integrity examples will be included in the workshop team exercises.

Target Audience:  New or experienced quality system auditors and audit program managers will benefit from attending.

Cost:  $400 (Coffee and Lunch are included)

A minimum of 8 students must registered by November 1 to conduct this course.

No refunds will be provided for cancellations after November 1.

 Registration:  https://www.eventbrite.com/e/2-day-hands-on-workshop-writing-exceptional-audit-reports-tickets-38607078812

 Speaker:  Mary Chris Easterly (ASQ CQA, CMQ/OE, CPGP, CSQP, past ASQ Raleigh section Chair):

  • Associate Director, Quality System Improvements, and Quality Risk Management Champion, Merck
  • 30 years in FDA regulated industry in auditing and other quality system and technical roles
  • Conducted global quality audits and internal audits
  • Presented this workshop at Audit Division Conferences and ASQ Raleigh Quality in the Triangle conference
  • Participated in the ASQ Certified Pharmaceutical GMP Professional initial exam development and handbook writing processes
  • Participated in ASQ Certified Supplier Quality Professional exam writing and exam review workshops
  • Reviewed ASQ Certified Quality Auditor Handbook, 4th edition and Biomedical Quality Auditor Handbook, 3rd edition
  • Taught CQA exam preparation courses
  • Presented at industry and ASQ conferences on quality system and auditing topics

 

Details

Start:
November 10 @ 8:30 am
End:
November 11 @ 5:00 pm
Event Category:

Venue

NC State University Club, Wolfpack Conference Room
4200 Hillsborough Street
Raleigh, NC United States
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