7-8 October 2013 - ITC GRAND CENTRAL, Mumbai

An Advanced Executive SeminarIntroduced in India by CorporatEdge

PRODUCT SAFETY, RECALL & PRODUCT LIABILITY PREVENTION

By Randall Goodden

Recall and liability claims can destroy reputations and brand image of a company

A great threat to success in any indus try today is the possibility of a devastating recall that can destroy reputation and brand image of a

company as well as raise consumer safety issues.

Industries with potential for Product Recall

• Automobile Industry

• Auto Ancillary Industry

• Food Industry

• Pharmaceutical Industry

• Medical Equipment & Devices manufacturers

• Cosmetics

• Tobacco Products

• Toy Industry

• White Goods Manufacturers

US$ 8 MILLION = COST OF EACH PRODUCT RECALL

“According to a study released by the American Society for Quality, each product recall costs an organisation, on an average, more than

$8 million. This conservative estimate includes reimbursement expenses to consumers, recall execution costs, and compensatory

damages from litigation. It does not include lost sales due to reduced marketplace credibility and lost market share.”

Recent Recall Statistics

• Chrysler recalls 1.6 million older Jeep Cherokees & Liberty SUVs -19 June 2013

• Zydus Pharmaceuticals recalls one lot of Warfarin tablets from the market -13 June 2013

• Volkswagen recalls as many as 38,000 vehicles of specific model over gearbox complaints – 12 June 2013

• Glenmark Generics recalls multiple lots of Montelukast Sodium tablets – 23 May 2013

• US recalls Indian hand-made dolls citing safety hazard – 26 April 2013

• Lighting Science Group recalls 5.54 lacs LED bulbs – 19 March 2013

• Ranbaxy recalls certain lots of specific strengths of Atorvastatin tablets due to possible contamination – 9 Nov 2012

• Car makers like Ford, Honda, Toyota and Nissan, amongst others have resorted to recall of over 1.5 lakh vehicle in India since July 2012

Impact of Recall- Ranbaxy

• Agreed to pay USD 500 million in civil & criminal fines under a settlement with US Department of Justice

• Shares plummet 17%

• 3 year import ban in the US for over 30 drugs

• Forfeited 180-day exclusivity on 3 drugs which translates to around US$300 million in lost opportunity

• Had to surrender new drug applications on 27 compounds

“Despite the growing trend of product recalls globally, Indian companies don't have a comprehensive strategy to tackle the threat,

…” ET bureau 25 April 2010

With so much potential risk riding on every product launched and exported into the marketplace, be it a commercial or consumer product, it’s

ALARMING how ill-prepared many manufactures can be in the area of Product Recall and Prevention.

For manufacturers with little, or no experience in the world of product recalls, a sudden unexpected occurrence could prove to be financially

devastating.

Do you have a Recall Prevention plan in place?

In today’s borderless economy, your only option is to protect your critical interest by implementing product safety and quality improvement processess in your organisation… not only as a self defense, but also to protect your cross-border business interest in countries with stringent Product Safety and Recall Laws. Join the world’s foremost expert on Product Safety and Recall Prevention, Randall L. Goodden, as he helps you bring substantial progress in product manufacturing practices and reducing the risk of RECALLS.

LEARN about Product Safety, Recall & Prevention

… from the Expert

Randall Goodden – The Expert

• A leading authority on Product Safety, Recall & Product Liability Prevention

• Conducts seminars in USA, Canada, Europe, Japan, Switzerland, China, Malaysia, Singapore

• Author of 3 best selling books on the topic

• Author of hundreds of articles that are published in business, trade and professional publications.

• President of the International Product Safety & Liability Prevention (IPSLP) Association

• Chairman of the American Society for Quality's Product Safety & Liability Prevention

Division

• Key speaker at the 4th Biennial United States-China Consumer Product Safety Summit

Randall Goodden – The Expert

This advance executive workshop is designed to be:

• PRAGMATIC Based on proven skills, speaker’s in-depth knowledge and expertise in product safety and recall prevention; the course material and concepts can be implemented as soon as you return to the workplace.

• PARTICIPATIVE This workshop is designed to be interactive and participative: Class lecture, team projects and networking sessions contribute to the learning process.

• SOLUTIONS-ORIENTED The hands-on exercises and consultative sessions provide a unique forum to address today’s concerns with complex regulatory environment.

THE AGENDA- INTRODUCTION SESSIONMODULES 1-6

• MODULE 1 PRODUCT RECALLS – AN OVERVIEW

• Recall statistics and trends • Costs to manufacturers • Case studies • Primary causes

• MODULE 2 RECOGNIZING AREAS INVOLVED IN PRODUCT RECALL PREVENTION

• Key areas that need to be under control

• MODULE 3 INTERNATIONAL REQUIREMENTS AND ISO 10393

• International reporting requirements • Insurance considerations • Expected requirements of ISO 10393

• MODULE 4 PREVENTING A RECALL - THE ROLE OF THE DESIGN REVIEW TEAM

• Understanding the objective • Tools for controlling the process • Complying with regulatory requirements • Identifying potential failure points

• MODULE 5 PREVENTING A RECALL - THE ROLE OF THE PRODUCT SAFETY TEAM

• Understanding the objective• Creating the Product Safety Team • Identifying potential hazards • Determining severity & probability

• MODULE 6 SUPPLIER SELECTION AND CONTROL • Determining Criteria for the selection of suppliers • Monitoring supplier production • Tracking incoming materials by batches • Building comprehensive traceability into final products

THE AGENDA – WORK SESSIONMODULES 7-11

• MODULE 7 RECALL READINESS - CREATING THE CORPORATE TEAM

• Members of the Recall Team • Knowing your recall options • Developing control procedures

• MODULE 8 RECOGNIZING THE “FLAGS” OR KEY PROBLEM INDICATORS

• Monitoring incoming • Customer Service calls • Training and reporting procedures • Getting important information to the right people

• MODULE 9 INVESTIGATING REPORTED PROBLEMS / INCIDENTS

• Immediately communicating with customer/end user • Testing products to verify allegations • Traveling to locations to inspect alleged defective

products

• MODULE 10 ‘DECIDING’ TO RECALL A PRODUCT • Reviewing a product issue with the Corporate Team • Making the final decision • Initiating a recall – ‘Timing is everything’ • Reporting requirements

• MODULE 11 RECALL READINESS - FINAL THOUGHTS

• How Customer Complaints become ammunition for lawsuits

• Annually review your Recall Procedures – Mock Drill

• Review your actual product and supplied part traceability

• Insurance and Legal considerations

• FINAL DISCUSSION SESSION

Key Learning

• How to establish a comprehensive Product Liability Programme to prevent catastrophic

losses

• How to implement safeguards to help avoid future legal actions and losses

• How to become significantly involved in Product Liability Litigation Management

• How to identify failure points, establish the role of individuals in a crisis, assess

organisational recall readiness, recognise red flags and decision making strategies in

crucial times

• How to minimise your organisation's product recall vulnerability.

• How to substantially increase your chances of winning future cases

Testimonials

"The seminar was exceptional and represented one of the highest values of any seminar I've attended in my 25 years in industry".      Kenneth McHenry - VP of Business Development, Effikal International

"I thought the Product Safety & Liability Prevention seminar was excellent! For me as an oversees Product Safety Advisor, this seminar was invaluable to understand the American system. I certainly recommend those working with product safety, both Americans and oversees, to attend your seminars".      Johnny Persson - Product Safety Officer, Tetra Pak, Sweden

"This seminar was very good, and did what I was hoping it would do which was to describe the product liability landscape in a very comprehensive manner. By having our team attend together, it enabled us to have a common frame of reference which facilitates better dialogue and strategic thinking. I also appreciated the wealth of real cases you were able to draw on to bring home your points".       Guy La Salle - Director of Product Safety & Regulatory Compliance, Nike

Who should attend?

• CEO

• CFO

• Legal Head

• Quality Head

• Head of R & D/ Technology

• Head of Engineering

• Legal Managers

• Quality Control Managers

• Production Managers

• Design Managers

• Risk Manager

PARTIAL CLIENT LISTSiemens,

Dell Computer,

Harley-Davidson,

3M,

Segway,

Panasonic,

Rockwell Automation,

Motorola,

Sony,

Shimano,

Nokia,

La-Z-Boy,

Steelcase,

Mazda North America,

DuPont,

Bombardier,

Hasbro,

Microsoft,

Pitney Bowes,

Bridgestone,

IBM,

Cooper Industries,

Mead Johnson,

Nike

Sandvik,

Renault,

GE,

AO Smith,

Dresser Inc,

John Deere,

Milwaukee Valve,

Owens Corning,

SC Johnson,

McDonald’s,

Toyota Motor Thailand,

Walt Disney Company

Snap-On,

Electrolux,

Toys R Us,

Simmons Bedding,

Kawasaki Motors,

Best Buy,

Umicore,

Effikal International,

Honeywell,

Coca Cola,

General Motors Thailand,

Parker Hannafin,

BSH Home Appliances,

Johnson Outdoors,

Alcoa,

Shure Inc,

Osram Sylvania,

L’Inglesina Baby,

ITW,

Carrier Corp,

FMC FoodTech,

Sears,

TRW

Thousands of key decision makers from corporations large and small have already benefitted from these training sessions in the United States, Europe, China, Thailand, Malaysia, Australia, and India

Registration Information Dates: 7-8 October, 2013

Venue: ITC, Grand Central, Parel, Mumbai

Timing: 9:00 – 5:00

Contact: Rupa Mehta on

9820314311 OR

rupa2904@gmail.com

Visit:

For information about the author: http://randallgoodden.com/

For downloading form: https://sites.google.com/site/corporatedge33/courseamoved

For Summary about the seminar:https://sites.google.com/site/corporatedge33/home/summary-of-seminar

Investment

Early Bird Discount: Register Before 8th August 2013 = Rs.39,326*

Register Between 9th August-8th September 2013 = Rs.41,573*

Register After 8th September 2013 = Rs.44,944*

*The amounts are inclusive of Service Tax.

Refund Policy

• We will give you a full refund if you cancel before 31st August 2013

• Cancellations between 1st September – 14th September will be charged a cancellation fee of Rs.10,000

• After 14th September 2013 no refunds will be given. However, substitutions will be allowed.