Deviations, Investigations and CAPA Workshop

https://www.pda.org/chapters/north-america/west-coast

Parenteral Drug Association West Coast Chapter

Deviations, Investigations and CAPA Virtual Workshop

This is a hands-on workshop that gives you ample time to practice what you learn and will cover the following topics:<ul><li>Examples of Sources of Failures</li></ul><ul><li>Definitions</li></ul><ul><li>FDA Expectations for Investigations</li></ul><ul><li>Documentation Guidelines</li></ul><ul><li>Writing Deviations – Problem Definition/Impact Assessment (Risks/Liabilities)/Material Disposition</li></ul><ul><li>Group Activity - Break into groups to write an effective problem definition and do Impact Assessment (topics to be given will include API issue, Drug product issue, temperature excursion, labeling issue, shipping issue, complaints)</li></ul><ul><li>Performing Root Cause Analysis - Review different methods for RCA (5 Whys, Fishbone/FMEA Analysis/Brainstorming, Pareto Charts/Trend Charts)-Spokesperson for each group to present their work to the audience for critique/improvement.</li></ul><ul><li>Group Activity - Continue with the problem definition to do a RCA- Spokesperson for each group to present their work to the audience for critique/improvement.</li></ul><ul><li>Developing an effective CAPA plan for the same scenario above</li></ul><ul><li>Group Activity-Continue with the investigation to do a CAPA- Spokesperson for each group to present their work to the audience for critique/improvement.</li></ul>After the completion of this course, you will be able to:<ul><li>Improve your ability to write a clear, concise deviation report</li></ul><ul><li>Perform a thorough investigation</li></ul><ul><li>Write an effective CAPA plan</li></ul><ul><li>Minimize regulatory liability by appropriately documenting findings</li></ul><ul><li>Enhance your understanding of what the FDA expects to see from a deviation/CAPA reporting system</li></ul>About the instructor:

Lisa Helmonds is Vice President of MWA Consulting, Inc. She has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical, biotechnology and medical device industries. She has extensive GxP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry. She holds a BS in Zoology from the University of Rhode Island and an MBA from Santa Clara University. Her current focus at MWA Consulting is on developing and maintaining relationships with MWA’s clients, implementing training programs, and ensuring that MWA’s consulting team continues to offer the highest quality consulting services in the industry.

Agenda:8:30 am - Check in4:30 pm - Closing5:00pm - <a href="https://www.eventbrite.com/e/21st-century-cgmp-training-tickets-72751827675" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Complimentary entrance to the &quot;21st century cGMP training&quot; seminar</a> (optional to attend, pre-registration required)

<h3></h3><h3>FAQs</h3>How can I contact the organizer with any questions?You can contact the event organizer sending an email to <a href="http://rsvp@wccpda.org" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">rsvp@wccpda.org</a>, please allows few days for the response, emails will not be monitored on the day of the event.Is my registration fee or ticket transferable?Ticket is not reimbursable, however you have time until 10 days before the event to transfer it to whoever would like to attend in your behalfMy company would like to become a WCC PDA Sponsor, do you have a sponsorship program?Yes, our <a href="https://docs.google.com/document/d/1LsTomwOJMojTWaPUhxOi6eM46er69W9Wi0jErbnbX4E/edit?usp=sharing" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">WCC PDA Sponsorship Program</a> offers a unique opportunity for companies that want to strengthen brand image, increase visibility, and gain access to leaders of the San Francisco Bay Life-Science CommunityWhat is the dressing code?Business casualCancellation Policy: Dinner seating is confirmed and reserved in advance. We regret that no refunds can be offered for non-attendance. If a registrant cannot attend, substitutions are welcome until 10 days before the event. The chapter reserves the right to cancel a dinner meeting if the minimum number of attendees is not met by Monday prior to the event. The chapter reserves the right to not answer emails or phone calls on the day of the eventPrivacy Policy:We manage your personal data responsibly and align with <a href="http://pda.org/privacy-policy" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">PDA privacy policy</a>.REGISTRATION AGREEMENT: by registering to this event I consent the WCC PDA to record and/or photograph me and using those recording and/or photographs in the future WCC PDA promotional and marketing material, and to send me promotional information via email.

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Deviations, Investigations and CAPA Workshop

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