Webinar - Change Control Hot Topics: FDA/Global Regulatory Inspections

RECORDING

Recorded: Tuesday, September 15th, 2009

11:00 a.m.-12:00 Noon, Eastern Standard Time (United States)

Instructor: Eldon Henson, Director API Products and R&D Quality

Covidien (formerly Mallinckrodt)

➢Purchase the Recording in our enKap Store

The low $139.00 Webinar RECORDING fee includes:

➢PowerPoint Presentation (PDF)

➢Change Control Audit Checklist specifically designed to address recent FDA/global regulatory body citations and “hot topics”

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

Webinar Content

➢FDA requirements for a change control program - Drug products, Medical devices, Active Pharmaceutical Ingredients (APIs)

➢“Hot topics” from the FDA (including specific examples from Warning Letters, 483’s, and other sources from 2008 – present) regarding: Documentation of changes, Approval of changes, Rationale for changes, Validation of changes, Use of risk assessment to evaluate changes, Importance of assessing changes both looking forward and looking backward, FDA’s view of “like-for-like” changes, Inclusion of changes in annual product reviews, “Mandatory” changes, Management of computer system changes

➢International regulatory “hot topics” on change control, such as: Why do we need to assess the impact of productivity and capacity changes on quality operations?, When is like-for-like not really like-for-like?

➢Assessing your own change control program: Specific actions that can prevent similar issues in your operations – for each Warning Letter or 483 example noted, a specific action which might have prevented the citation will be discussed, Use of the Change Control Audit Checklist (provided free of charge to all webinar participants) to identify and bridge potential compliance gaps

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 IN THIS WEBINAR

In this webinar, you will review the basic requirements for a strong change control program as defined for drugs, devices and API’s. Most of the webinar will focus on current “hot topics” relating to change control.

We will review specific Warning Letter and 483 observations noted by the FDA, discuss the specific deficiency, and identify specific actions that could have prevented the observation.

The “hot topic” areas encompass the areas of change documentation, change approval, change rationale, validation, use of risk management tools, forward/backward assessments, like-for-like changes, inclusion in annual product reviews, computer system changes and more.

Additionally, we will review recent international regulator comments regarding the direction of FDA/global regulatory body inspections related to change control.

The overall goal of this webinar is to aid you in assessing your current change control program in light of current FDA and international expectations, then design and implement remedies to bridge the gaps.

WHO SHOULD ATTEND THIS WEBINAR

This webinar is designed for “Change Control practitioners” – those individuals in quality assurance, quality control, compliance, regulatory affairs, manufacturing, or other key groups that originate, review/approve, execute, document, or verify effectiveness of changes, and those individuals that present or defend these programs during FDA or other regulatory inspections.

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 complinance, 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 four segments: 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.

➢Purchase the Recording in our enKap Store