WEBINAR Recording-The Seven Deadly Sins of Failure Investigations

Recorded Tuesday, November 17, 2009

11:00am – 12:00pm -Eastern Daylight Savings Time-United States

INSTRUCTOR: Eldon Henson, Director API products and R&D Quality, Covidien (formerly Mallinckrodt).

This Recording is now part of a CONTENT Package - Click Here to Read More

➢Invite as many co-workers as possible for this training. Quality content training for one low price (only ONE login allowed - must be in one location). In addition you also receive:

➢Powerpoint Training Presentation

➢Webinar Recording

➢Audit Checklist Outline: Areas to Consider When Performing a Failure Investigation

➢Free Membership in enKap's FDA Compliance learning community - simply fill out a profile

WEBINAR SUBJECT MATTER CONTENT

FDA requirements for failure investigations --- What the basic requirements are for conducting a successful failure investigation in a GXP environment (drugs, medical devices, clinical studies, laboratory studies, etc...)

• The “CSI” Example for an Effective Investigation --- Lessons learned from the approach taken by Crime Scene Investigators for investigations

The “Seven Deadly Sins” for Failure Investigations --- Seven key issues listed below continue to appear in recent Warning Letters relating to failure investigations. We will discuss each of these issues with Warning Letter examples and specific actions that could prevent the deficiency.

The Seven Deadly Failure Investigation Sins:

o Root cause not identified or incorrect

o Investigation not extended to other products, other lines, or other potentially impacted activities

o Inadequate or undocumented investigations

o Lacking or poor scientific rationale for investigation conclusions

o Lack of urgency for completing investigational activities

o Inadequate investigation close-out (poor conclusions, inadequate follow-up, or inadequate corrective or preventive action)

o Inadequate oversight, review, or approval of investigations conducted by contract manufacturers or laboratories

Specific Activities That Can Help Prevent Similar Deficiencies In Your Investigations

o Conduct a gap analysis of recent Warning Letter observations versus your current operations

o Assess your current operation against the audit checklist that will be provided as part of this webinar

o Bolster failure investigation procedures to address the "Seven Deadly Sins" for failure investigations

Potential Future FDA Regulatory Enforcement “Hot Topics” Relating to Failure Investigations

o Failure to identify and correct secondary root causes

o Lack of investigations to address management failures

o Failure to apply risk management tools

o Other issues to be discussed in the webinar

QUESTIONS AND ANSWERS

There will be a 15-minute question and answer period for attendees to submit questions. If we are unable to answer your question due to time constraints, our instructor, Eldon Henson, will provide an email response after the webinar concludes.

WHAT ATTENDEES WILL LEARN FROM THIS WEBINAR

In this webinar, we will review the basic GXP requirements for failure investigations, including out-of-specification, manufacturing, complaint, and other investigations. We will compare and contrast a GXP failure investigation with that taken by a CSI (Crime Scene Investigator) team. Additionally, we will review the “Seven Deadly Sins” for failure investigations – those seven items appearing repeatedly in recent FDA Warning Letters impacting failure investigations. We will discuss each of these issues with specific Warning Letter examples, and discuss actions that could prevent the deficiency. Finally, we will examine some potential future “hot topics” relating to failure investigations that will likely appear with increasing frequency related to FDA enforcement.

WHO SHOULD ATTEND

This webinar is designed for any Quality Unit, management, corporate personnel, or leader in a GXP firm that is involved in the generation, review, or approval of failure investigations. This webinar will focus on specific applications that can prevent deficiencies. In short, this webinar should be of value for all professionals involved in failure investigations.

This Recording is now part of a CONTENT Package - Click Here to Read More

ABOUT YOUR INSTRUCTOR

Eldon Henson is currently Director API products and R&D Quality, Covidien (formerly Mallinckrodt). He has worked primarily in the areas of quality assurance and compliance, although he has considerable experience in manufacturing, quality control and R&D for firms that include Novartis, Abbott, Boehringer-Ingelheim and others. These firms represent solid dosage forms, aseptically processed products, liquids, medicinal nutritionals, biopharmaceuticals, APIs and foods..

******During his career, Mr. Henson has over 3000 hours of direct contact with FDA investigations, most of which were related to quality systems.******

Covidien Pharmaceutical

Covidien is a leading global healthcare products company which manufactures, distributes and services a diverse range of industry-leading product lines in foursegments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries.