Lothar Hartman, Managing Director, PhACT, and Chair of PDA Quality Systems Interest Group | Apr 01, 2019
Quality systems are a key element of any pharmaceutical operation. In light of significant recalls due to manufacturing issues, quality systems are more critical now than ever. Fortunately, PDA members have a resource to expand knowledge in this area: The Quality Systems Interest Group.
The Quality Systems Interest Group offers a forum for discussions on current topics and coverage of developments related to quality systems based off ICH Q10: Pharmaceutical Quality System.
The group’s intention is to exchange information on the topic, share best practices, offer open discussion and develop practical approaches.
The group has grown tremendously since it was founded not that long ago. Currently, the group consists of the following 11 subgroups: management review, key performance indicators/metrics, continuous process verification, process owner, quality risk management, comparability of ICH Q10 with ISO standards, quality management systems auditing, quality manuals, knowledge management, training and documentation control.
For more information, please contact the chair of the group directly.