Managing and Performing Audits of Quality Systems, Manufacturing Operations, Bioresearch, Etc.

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.

• This presentation is intended to enable non-experts to ask intelligent questions.
• Key issues include documenting programs, back-up/recovery and system security.

• 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

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.