Course Description:
This two day interactive in-person seminar will inform and prepare firms on how to conduct Root Cause Analysis for Out-Of-Specification (OOS) investigations. During the seminar, attendees will learn the core skills and tools necessary to successfully conduct such investigations and obtain a clear understanding of the steps, techniques, and methods used to identify the root cause of problems.
This seminar will provide valuable problem-solving skills that you can immediately apply within your organization to conduct complete and thorough OOS investigation to meet FDA expectations. It will also provide some examples of cause mapping methods for solving issues into its cause-and-effect relationships and proper documentation for detail OOS investigations so that everyone asks the right questions and has accurate information. Several OOS exercises will also be presented during this seminar
Seminar instructor Richard Aleman is an ex-FDA official having more than 28 years of experience working with the FDA as an investigator, biologics specialist, compliance officer, associate director of import operations, director of investigations, and director of compliance.
Day one of the seminar will begin with a high level discussion why we need to know how to conduct Root Cause Analysis. The instructor will also provide:
- A clear understanding of Root Cause and Root Cause Analysis
- Steps, techniques, or methods used to identify the root cause of problems
- Some examples of techniques and tools to use such as the use of Brainstorming and use of Fishbone diagrams
- Specific questions to ask when performing Root Cause Analysis, and
- Examples of Root Cause Maps as well as several root cause exercises
On day two, the instructor will focus on:
- Out-Of-Specification (OOS) Investigations
- FDA cGMP regulations regarding the handling of OOS results
- FDA expectations of OOS investigations
- Effectively handling OOS investigations, when to stop testing, and how to interpret tests results
- Portions of The Barr Decision of 1993
- The definition of Outlier Tests and Averaging of Test Results
Learning Objectives:
Attendees will learn how to:
- Analyze problems thoroughly and effectively
- Learn how to identify the root cause of a problem
- Communicate complex issues visually and verbally
- Take emotion, opinion and speculation out of problem solving
- Develop a process/systems approach when managing problems within your operations
- Anticipate problems to prevent them from occurring
- Prioritize problems more efficiently and objective
- Conduct complete and thorough OOS Investigations
If you were looking for answers to these questions, you would certainly benefit from attending this seminar:
- Why do we need to know how to conduct root cause analysis?
- What are some of the tools available to conduct successful root cause analysis?
- How to apply the basics of identifying root cause and root cause analysis to become better problem solvers?
- How to better define problems based on an organization's overall goals?
- How to conduct structured, objective, evidence-based analysis for problem solving, and identify the best solutions for improving an organization's processes?
- What are the FDA's expectations regarding complete OOS investigations?
- How to understand and comply with the FDA requirement regarding OOS investigations?
- How to protect your company against superficial and incomplete investigations?
- Why are responses to FDA 483s and Warning Letters critical?
- What are the steps for responding to FDA 483s and Warning Letter?
Who will Benefit:
This course will benefit personnel involved in quality or regulatory compliance for medical devices marketed in the European Union and it is ideal for quality, regulatory, and clinical professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.
|
Course Outline:
| Day One (8:30 AM - 5:00 PM) | Day Two (8:30 AM - 4:30 PM) | ||
|
Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM
|
|
Meet Your Instructor
 |
Richard Aleman, Ex- FDA Investigator President - Quality Regulatory Compliance, Inc. Richard Aleman began his career with FDA as an investigator in Dallas, TX in 1972 and held various positions in several field offices and headquarters including drug and biologics specialist, associate director of import operations, supervisor, director of investigations, and director of compliance until 2000. Mr. Aleman has 28 years of FDA experience and over 25 years of Supervisory/Management experience in the regulatory and enforcement areas, regarding FDA and international requirements and regulations, e.g. primarily managing Corrective and Preventive Actions, FDA 483 compliance corrections, responses to Warning Letter, etc., confronting the pharmaceutical, biologic, and medical device industries. He has conducted training, reviewed quality systems and provided guidance on quality, labeling and compliance issues. As an investigator he conducted only the most complex and novel of assignments culminating in setting FDA legal precedence for one of his investigations. Mr. Aleman has significant experience in the auditing of pharmaceuticals, medical device, biologic, veterinary drugs, dietary supplement, imports, and food areas. As a Supervisor, Director of Investigations, Compliance Officer, and Director of Compliance he managed through subordinates, Industry Consent Decree, and Warning Letters effecting the medical device, biologic, and pharmaceutical industries. He successfully completed numerous regulatory actions to bring firms and products into compliance. These actions included Warning Letters, Regulatory Letters, Seizures, Injunctions, Prosecutions, Inspection Warrants, License Suspension, License Revocations, working on grand jury investigations, and conducted a 305 hearing. After leaving the FDA in 2000, Mr. Aleman worked with the regulated industry, including Adams Laboratories, where he was the director of compliance and instrumental in getting the approval of an NDA for the drug product, Mucinex. He was also the director of compliance for Cardinal Health and Vintage Pharmaceuticals in Huntsville, Alabama. He began his career as a consultant in 2008, and he has worked extensively with the pharmaceutical, medical device, and dietary supplement industries to assist them in achieving compliance with the requirements of FDA laws and regulations. He served as the cGMP consultant and lead auditor for the United States Pharmacopoeia (USP) for four years, where he managed the auditing of USP’s Verification Program for Active Pharmaceutical Ingredients (APIs), Dietary Supplements, and Excipients. |
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
|
Local Attractions
Buckingham Palace:
It is the official London residence of the Queen and principal workplace of the British monarch. It is located in the City of Westminster. Open for tours during the summer months only, but a must-see sight even if you don't go in.
London Eye:
The London Eye is a giant Ferris wheel situated on the banks of the River Thames in London. The entire structure is 135 meters (443 ft.) tall and the wheel has a diameter of 120 meters (394 ft.). It is the tallest Ferris wheels in Europe and the most popular paid tourist attraction in the UK. London Eye is visited by over 3.5 million people annually.
Tower of London:
Situated just south east of the City, is London's original royal fortress by the Thames. It is over 900 years old, contains the Crown Jewels, guarded by Beefeaters, and is a World Heritage site. It is also considered by many to be the most haunted building in the world. If you are interested in that sort of thing it’s definitely somewhere worth visiting.
Tower Bridge:
Tower Bridge (built 1886–1894) is a combined bascule and suspension bridge in London, over the River Thames. It is close to the Tower of London, from which it takes its name. it has become the iconic symbol of London.
British Museum:
This museum in London is dedicated to human history and culture. Its permanent collection, numbering some eight million works, is among the largest and most comprehensive in existence and originates from all continents, illustrating and documenting the story of human culture from its beginnings to the present.
St Paul’s Cathedral:
St Paul's Cathedral, London, is a Church of England cathedral and seat of the Bishop of London. The cathedral is one of the most famous and most recognizable sights of London, with its dome, framed by the spires of Wren's City churches, dominating the skyline for 300 years. St Paul's Cathedral occupies a significant place in the national identity of the English population.
Madame Tussauds London:
It is a major tourist attraction located in Central London, housed in the former London Planetarium. It is famous for recreating famous people and celebrities, in wax.
National Gallery:
The National Gallery is an art museum on Trafalgar Square, London. Founded in 1824, it houses a collection of over 2,300 paintings dating from the mid-13th century to 1900.
