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GlobalCompliancePanel, Online Training Webinar
2011-05-25
Overview: Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective and/or preventive actions, and do proper impact analysis / actions. As such RCA is a major element of cGMP compliance, and is also a key source of regulatory problems. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can line operators' brains be engaged by the use of such simple yet powerful tools? Use RCA to facilitate a closed-loop problem resolution system to reduce “fire fighting” and minimize compliance problems.
Why Should You Attend: Expectations for meaningful, results driven root cause analysis that addresses and resolves underlying product problems are increasing among regulatory agencies world wide, with good reason. EU's ISO 14971 (Device Risk Management) and the FDA's QSIT and Q9, underscore this increased emphasis. A valid closed-loop CAPA system requires root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that effective root cause analysis is still not the industry norm. The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop RCA as an integral part of CAPA, Validation and Quality Management Systems / cGMP planning, implementation and execution.
Areas Covered In the Session: - Regulatory "Hot Buttons"
- The 4 Basic Steps to Problem Solving
- A Suggested Investigation Template
- ID / Document the Problem
- Investigation / Analysis Methodology - The 7 RCA "Tools"
- Find the Solution(s)
- Monitor for Effectiveness
- Lock In the Change - Close the Loop
- Take It to the Next Level
Who will benefit: - Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants; others tasked with product, process, CAPA resolution, failure investigation responsibilities
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
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Deadline for Abstracts:
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2011-05-25
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Registration:
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Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
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E-mail:
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webinars@GlobalCompliancePanel.com
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