Industries: Pharma / BiotechMedical Device

Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries™

Course Director: Lee Truax-Bellows

Course Description - Course runs 9:00 to 5:00 both days

A robust audit program is a key stone of an effective Quality System. The need for internal (self-inspection) quality auditing has been recognized, and is required, by all active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical cGMP regulations published worldwide. In addition it is starting to become the industry expected "norm" in the area of pre-market clinical development.

Experience reveals that many internal company quality audits and many external supplier/contractor quality audit programs are ineffective. This course provides the rationale, strategies, techniques and tips, on how to plan and perform effective audits.

The course explores the politics, psychology and all the technical aspects of auditing, including discussions of their logistics, tools, and frequency. The course evaluates the talents and personnel characteristics required of those who consistently perform thorough audits which yield optimal compliance results.

The name of the game is effecting change. Determining operational deficiencies is only one aspect of an audit. The key issue is how to effect change to bring about compliance to company and legal standards. This course considers how to effect change and how to make audits a positive experience for the auditor and auditee.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Who Should Attend

This two-day course is designed for quality managers, quality auditors, regulatory/compliance professionals, production managers and top management interested in learning the value of an effective internal and external quality audit system. Those interested in how to prepare for a QA audit and how to enhance their internal/external quality audit system as a valuable regulatory compliance tool will also benefit from this course. Consultants and government inspectors will find this course particularly useful in enhancing their inspections and capabilities.

Course Agenda

First Day

Overview and general considerations:

  • Scope and purpose of the internal and external Quality Audit System
  • Regulatory background – requirements for each type of operation
  • Understanding the politics of auditing
  • Auditing / Regulatory Inspections – the tie-in

Contractor and supplier audits

  • When to audit – initial evaluation versus re-certification
  • Steps for conducting supplier audits
  • Problem resolution audits

What makes a good audit?

  • Audit objectivity
  • Auditing standards
  • Creating a win-win audit - turning the audit into a positive coaching experience for yourself, your company, and those you are auditing

Selling quality assurance audits to management

  • Learn why top management should care about audit findings
  • Discover how to get management to listen, buy-in, and take action on your audit findings

Audit System

  • Define responsibilities
  • Ensure auditor qualifications and training
  • Developing an audit schedule – Risk Based
  • Preparation for the audit (developing audit conduct tools):
    • Audit Plans
    • Audit Checklists
    • Review of past history and additional background data
  • Auditor Best Practices:
    • Key questions
    • Techniques
    • The importance of documentation
    • Listening & observation skills
    • What to do and what not to do
  • Conclusion-Audit reports
    • Categories of observations
  • Effecting change

Audit Follow-Up and Closure

  • Follow-up and final documentation
  • Audit Closure
  • Audit Reports
  • Relation to CAPA

Second Day

Conducting Audits

 

  • Review key areas for each type of audit focus. Will include what to look for and questions to ask when conducting the following types of audits
  • Good Clinical Practice Audits
    • Planning
    • Scheduling
    • Audit Conduct – key areas of focus
    • Reporting of audit results
  • Good Laboratory Practice Audits
    • Planning
    • Scheduling
    • Audit Conduct – key areas of focus
    • Reporting of audit results
  • Good Manufacturing Practices/Quality System Audits
    • Planning
    • Scheduling
    • Audit Conduct – key areas of focus
    • Reporting of audit results

Learning Objectives

This course is designed so that you will:

  • Know what is involved with an effective internal and external quality audit, and how to plan for its successful implementation
  • Understand the types of QA audits which are conducted, why they are necessary and the value they provide
  • Learn how to prepare for conducting an audit, achieving closure and how to get the best out of your quality audit system
  • Connect these audits with your corrective and preventive action (CAPA) programs
  • Be able to "sell" management on implementing effective internal quality audits and supplier/contractor audits

Testimonials

"I very much appreciated the real world experience and relevant story telling by the instructor. The small class size was helpful. The accommodations (meals, hotel, etc.) were also great! I look forward to the next course." Richard M., Quality Assurance Associate, Evidera
"I enjoyed the Training VERY Much. Thank you for all your time, expertise and help, as I gained a lot from the course and from you as the trainer." Kelsey, QA/RA Specialist, Reliable Biopharmaceutical
"The Course Director did an outstanding job explaining FDA style audits as was what to look for when performing an audit (internal or external). This is the best quality auditing course I have attended!" Keirstein T., QA Compliance Specialist, Cell Genesys
"The Instructor was very knowledgeable and pleasant. I felt comfortable initiating discussions and welcomed their responses. I feel I have gained a lot of helpful information and resources, and I see myself consulting the instructors in the future." Brooke S., Regulatory Compliance Manager, Glaxo (GSK)

"Well defined course for all FDA Regulated industry Auditors. The instructor kept it alive. I enjoyed this course." Paul G., Quality Assurance Manager, Med-Health Pharma
"As a new compliance official and soon to be lead auditor, this course gives me the background and knowledge to pursue audits with confidence and competence." Kristin S., R&D Quality Assurance GMP Manager, Sanofi Pasteur
"The Course Director was highly educated and experienced! Lectures were mixed with team exercises, which is a great way to learn. I will - with great pleasure - recommend CfPIE as a great training provider for people in the pharmaceutical business." Kelly J., Project Coordinator, Octapharma AB
"The instructor was extremely knowledgeable with the material and encouraged participation. The case studies and exercises were helpful and individuals were given the opportunity to weave their own issues into each workshop." Ellen H., Regulatory compliance, BD Bioscience
"Very engaging and knowledgeable instructor - kept me interested from start to finish, and even got me excited about quality!" Sonia G., Quality Engineer, Johnson & Johnson
"The Course Director was very open with suggestions and very knowledgeable. Information provided was extremely valuable. I would like to attend another course given by the same instructor." Regina W., Document Control Coordinator II, Shire Pharmaceuticals
"The instructor's enthusiasm was contagious and made the course enjoyable." Bonnie B., Production Manager, IBA Molecular NA
"The Course Director was very knowledgeable in the subject matter and the presentation was very well organized. I really enjoyed the exercises. I learned a lot! Great job!" Cristen G., QA CAPA Specialist, IBA Molecular
"The Course Director was very knowledgeable. This was an incredible, informative course." Dale B., Sr. QA Manager, Ception Therapeutics