Risk Management Seminar by Joe Brady
16 June 2009
Schering Plough
On 16 June 2009, the Singapore Affiliate held a seminar on “Effective and Efficient
Application of Quality Risk Management for The Pharmaceuticals and Bio
Pharmaceuticals Industries at Schering Plough's facility. The seminar was presented
by Joe Brady of DPS Engineering.
The crux of the presentation was to demonstrate an effective, efficient and a practical
user-friendly approach to quality risk management commensurate with the level of
risk. It focused on product quality, patient safety and business hazards, the
presentation covered the application of risk management to specification, design and
verification of manufacturing systems, processes and procedures.
The presentation emphasised a lean approach to policies and procedures intended to
maximize the flexibility and maintain the integrity of the risk assessment tools and
processes. It discussed planning a risk based strategy initiated by a well defined risk
question within a specific context.
The presentation enlightened companies to the untapped potential and expertise of
their existing employees and contractors who could immediately contribute to many
risk based tasks. It helped to identify the optimum personnel who could contribute to a
risk exercise. It also looked at ways to optimize the performance of, and motivate, a
risk assessment team.
Finally the presentation suggested minimum standards for documenting and reviewing
strategies for each step of a quality risk management process.
This seminar will be held in-house for Genentech employees in July.
If you would like to run this seminar in-house at your company, contact Martina
Crosbie at ispesingapore@yahoo.com.sg for more information.