ValSource Experts Share PDA’s Newest Approach to Risk-Based Thinking

Four ValSource consultants are featured presenters and moderators at the Parenteral Drug Association (“PDA”) Quality Risk Management for Manufacturing Systems Workshop. The workshop takes place June 19-20 at Hyatt Centric Chicago Magnificent Mile in Chicago, IL. ValSource’s Hal Baseman, Lori Richter, Christopher Smalley and Kelly Waldron, together with key industry and regulatory leaders, will share their expert opinions on the value and role of quality risk management in the modern manufacturing system lifecycle.

The Workshop is based on PDA’s practical and effective approaches to using QRM for key decision making in the lifecycle of manufacturing systems, which will be published in the upcoming PDA Technical Report No. 54-5, PDA Quality Risk Management for the Design, Qualification and Operation of Manufacturing Systems. Attendees will apply the principles outlined in TR 54-5 with the guidance of the primary authors and regulators.

“By design, this workshop is highly interactive,” comments ValSource Chief Operating Officer Hal Baseman. “Attendees will participate in breakout sessions and encourage dialogue on such important topics as the use of QRM approaches for the characterization of critical aspects of system design, the qualification of those systems and the integration of QRM principles into the pharmaceutical manufacturing system.”

During breakout sessions, attendees will perform a hands-on risk assessment of a given process and use the information to develop lifecycle-focused quality system plans and approaches for commissioning qualification and validation, change control, deviation management, CAPA and investigations. After the breakout sessions, the groups will reconvene to share results, ask questions and identify remaining challenges.

Project engineers, project managers, commissioning and validation professionals, quality assurance personnel, auditors and decision makers are encouraged to attend. For more information and to register, visit or call 301-656-5900 ext. 115.