Managing and Performing Audits of Quality Systems, Manufacturing Operations, Bioresearch, Etc.: One and a Half Day In-Person Seminar

By: Bill Schwemer, Principal, Schwemer Consulting and Former Senior FDA & Industry Official
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Course Description:

This course is ( not “will be”) based on corporate procedures for audits and FDA requirements/expectations for audit programs. Conceptually, it will be applicable to all industries. It has been designed to set forth elements of auditing compliance with regulations, company procedures, and generally recognized good business practices. The subject matter is applicable to internal, external (supplier/contractor) and due diligence audits.

This seminar will discuss comprehensive coverage of a quality system along with a more efficient, targeted approach. Basic elements of auditing laboratories, computer systems, design controls, and validation will also be reviewed. Further, the course will:

  • Define fraud, identify fraud indicators, and contrast fraudulent activities with what amounts to poor performance.
  • Provide a standard against which a company’s current audit procedures can be evaluated.
  • Discuss the use of checklists and draft letters and many of them will be embedded into visuals as examples.
  • Demonstrate how organizations that lack an audit program can adopt the audit procedures detailed in the course or use them as a basis for developing their own procedures.
  • Include a workshop with small groups to consider real audit situations and discuss approaches to dealing with them.

Seminar instructor Bill Schwemer is an ex-FDA official with more than 50 years of experience in dealing with FDA compliance matters that include 30 years he spent working with the FDA as a field investigator, director of field investigations, assistant associate commissioner for regulatory affairs, and special assistant to deputy commissioner for policy.



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Learning Objectives:

  • Recognize the elements of an effective, efficient audit program that are included in:
    • Program Management
    • Conduct of Audits
    • Reporting Findings
  • Understand the knowledge, skills and/or abilities needed for performing audits.
  • How to evaluate documents and records that compose a quality system.
  • What to look for when performing audits against company policies, regulatory requirements, and other standards.
  • Enable an audit team to find weaknesses that should be corrected before they are found during a regulatory inspection.
  • Identify opportunities for participants and their staff to improve audit programs.
  • Learn how audit findings can be scored to measure improvement or regression from one audit to another.
  • How to spot apparent fraud, but not confuse it with sloppiness or poor performance.
  • Understand the importance of communications between auditors and those audited; then maintaining open, cooperative relationships following audits to resolve issues.

Who Will Benefit:

  • Corporate, site, and department managers responsible for reviewing audit resource needs and budgeting.
  • Senior managers wishing to improve communications between corporate or site auditors and the businesses or departments audited.
  • Quality, regulatory, and purchasing department personnel who base decisions on audit findings.
  • Audit program managers looking for more efficient and effective approaches.
  • Managers, supervisors, quality assurance staff, technical specialists and others who are assigned to audit teams.
  • Supervisors and managers that host regulatory inspections and customer auditors

Course Outline

Day One (8:30 AM – 5:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
  • 9:00 AM - 9:15 AM: Introduction of Course Participants
  • 9:15 - 9:45 AM: Definitions and Audit Types
    • Define audit.
    • Contrast different types of audits.
    • Provide an easy read concerning internal audit programs.
  • 9:45 - 10:30 AM: Managing an Audit Program
    • Systematically walk participants though elements of an audit program.
    • After two presentations, present a model audit SOP.
    • Examples of checklists for quality and clinical audits.
  • 10:30 - 10:45 AM: Break
  • 10.45 - 11:30 AM: Let’s Go Auditing
    • Auditors/teams prepare well in advance of agreed dates.
    • Modify audit plans to deal with new information or problems observed on-site.
    • Auditors are not simply verifiers, they:
      • identify inadequate procedures and
      • controls,
      • investigate unusual/non-compliant situations, and
      • document observations.
  • 11:30 - 12:00 PM: Reporting Findings
    • Importance of audit reports in:
      • classifying findings,
      • communicating objectionable conditions, and
      • maintaining good relationships with auditee.
    • Should audit reports be retained or destroyed following CAPAs?
  • 12:00 - 1:00 PM: Lunch
  • 1:00 - 1:30 PM: Evaluating Documents and Records
    • Recognize document and record deficiencies.
    • Auditing data.
  • 1:30 - 2:15 PM: Performing Targeted Audits
    • Indicators of questionable, if not poor, practices can often be found in logs and databases.
    • Covering all products and/or departments superficially may not result in meaningful findings.
  • 2:15 - 2:45 PM: Break
  • 2:45 - 3:45 PM: Comprehensive Audits
    • Evaluate all pertinent manufacturing/control systems.
    • Ensure procedures address regulatory requirements, quality agreements, and other standards; and that they are followed.
    • Consider the approach: series of short audits, one lengthy one, or dispatching a large team.
  • 3:45 - 4:30 PM: Auditing Laboratory Controls
    • Testing raw/in-process materials and finished products is a critical aspect of quality assurance.
    • Achieving valid results requires:
    • staff with necessary knowledge/skills/ abilities,
    • qualified and well maintained/calibrated equipment, and
    • operational procedures and methods to direct work, including investigation of deviations and aberrant results.
  • 4:30 - 5:00 PM: Computer System Audits
    • This presentation is intended to enable non-experts to ask intelligent questions.
    • Key issues include documenting programs, back-up/recovery and system security.
    Day Two (8:30 AM – 12:30 PM)
    • 8:30 - 9:15 AM: Auditing Validation
      • Qualification of equipment and systems: correct installation and operation.
      • Validation studies produce evidence that products consistently meet specifications.
      • Changes in instructions and/or equipment may require re-validation.
    • 9:15 - 10:15 AM: Detecting Fraud
      • Fraud involves intent to deceive; it is seldom obvious.
      • Sloppy paperwork may have the appearance of fraudulent behavior.
      • Recognize signs or indicators of possible fraudulent practices.
      • FDA/EPA bioresearch programs and application integrity policies.
    • 10:15 - 10:45 AM: Break
    • 10:45 - 12 AM: Workshop
      • Breakout groups will discuss how to deal with real situations encountered during audits.
    • 12:00 - 12:30 PM: Q&A, Issue Certificates, and Close

    Meet Your Instructor

    Bill Schwemer
    Bill Schwemer
    Principal, Schwemer Consulting and former Senior FDA & Industry Official

    Bill Schwemer is an ex-FDA official with more than 50 years’ experience in FDA compliance matters. He was an FDA field investigator and compliance officer, a senior official with FDA's Office of the Commissioner, and was VP of RA/QA at a personal care products company. Mr. Schwemer has experience in all FDA program areas, but in recent years has consulted primarily with pharmaceutical and personal care products companies. He has published more than 125 articles, and, since becoming a consultant, has successfully served as a regulatory compliance expert witness in 22 lawsuits.

    Mr. Schwemer has unparalleled experience performing and managing audits/inspections in various capacities with responsibilities like: developing over 150 legal actions; developing an internal audit program and hosting EPA, OSHA, and local agency inspections and customer audits; managing all foreign FDA inspections and supporting investigations nationwide; accompanying corporate audit staff during site audits for firms that develop/manufacture pharmaceuticals, medical devices, and cosmetics; and evaluating corporate level audit programs for senior officials.

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