Duration: 60 Minutes


$390 

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Corrective Actions/Preventive Actions are an integral part of a robust quality system in both pharmaceutical and medical device manufacturing. The ability to be able to determine the root cause of a product or manufacturing issue and put effective corrections in place is critical to continued product quality. Understanding the process of root cause investigations and the appropriate corrective actions/preventive actions will help ensure continued product quality.


CAPA is a required part of both pharma and medical device quality systems. An understanding of the CAPA system and putting into place a robust process will help ensure quality products and smooth manufacturing.


Areas Covered in the Session :


  • Gain an understanding of the CAPA process
  • Understand the need for CAPA
  • Discuss inputs into the CAPA process
  • How to put a good process in place


Who Should Attend:


  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments

Course Director: Alan M. Golden


Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.

Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.

Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.

Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.

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Cancellation by Registrant:
  • Registrants may cancel their registration for any reason up to 2 business days prior to the event. A refund will be issued minus a $45 administrative fee.
  • If a cancellation occurs after materials such as documents, handouts, checklists, slide deck, or recordings have been sent by Eventura, only 40% of the registration fee will be refunded.
  • If the registrant fails to cancel within the stipulated time or does not attend the event, no refund will be issued. Options available to the registrant in such cases include:
    1. Access to a one-time recording of the event.
    2. A redeemable voucher.
Substitutions:
Substitutions of attendees may be made at any time by notifying Eventura via email.

Cancellation by Eventura:
  • Eventura reserves the right to cancel or reschedule an event due to insufficient registrations or unforeseen circumstances. Registrants will be notified via email prior to the event's start time unless prevented by situation beyond control.
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  • If the new date is not suitable, registrants may choose from the following options:
    1. Access to a one-time recording of the webinar after the live session.
    2. A redeemable voucher valid for 12 months, applicable towards any future live event or past recording.
  • A full refund will be issued if no new date is provided within 90 days from the originally scheduled event date.
Event Cancellation:
If an event is permanently cancelled, registrants may opt for:
  • A recording of the webinar, if available.
  • A redeemable voucher.
  • A full refund.
Changes to Event Details:
Eventura reserves the right to modify some topics, materials, or speakers/instructors without prior notice.

Refund Processing:
Refunds are processed within 7 business days from the receipt of the refund request. Eventura World is not liable for any penalties or expenses incurred due to an event's cancellation.

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