Pharma / BiotechMedical Device
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.
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.
Overview and general considerations:
Contractor and supplier audits
What makes a good audit?
Selling quality assurance audits to management
Audit Follow-Up and Closure
This course is designed so that you will:
"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
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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