Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Deb Simpson

Change control, is by its nature and scope, is the most significant QMS intersection. Yet there are no specific QMS regulations that clearly define all areas to be considered. Rather, the scope is defined by the products, processes, and related regulations. Document control is an element of change control, as well as one of the feeder systems, and is also an outcome of change control. In process terms, document control can be an input, a process step and an output of the change control process. Document control is a foundational element of the QMS and provides the structure and support for many other elements, including change control and CAPA.

Yet, there are many other elements to be considered. Design control and related product changes and process changes can be both inputs and outputs of the change control system. Validation requirements can drive change control or be driven by change control. CAPA is often a feeder for change control system, however, the output of the changes can be a source of evidence for CAPA action completion and effectiveness evaluations. In short, all areas of the QMS may be involved in the change control process, resulting in a complex and varied intersection (s), unique to each QMS. CAPA has consistently been among the top five causes for issuance of FDA audit findings for many years. This QMS areas is almost always reviewed during regulatory or QMS audits. Changes required to implement corrective and preventive actions must be tracked and documented. Evidence of the effective implementation of these changes must be provided back to the CAPA system. Linkage of the CAPA file to the changes must be readily available. Therefore, CAPA and change control are interdependent sub systems of the QMS.

Electronic systems make repetitive control tasks more efficient and consistent, However, electronic systems must meet the same control requirements of paper based systems, and this is often misunderstood. Changes to an electronic system may result in issuance of a change control, or may be the result of a change control activity. For example, updates to an electronic system or software could trigger a change control. Which could then impact supporting systems such as validation. Or changes in the procedure for using the electronic system could result in the need to revise the system itself. No other aspect of the QMS is as misunderstood as change control. No other QMS element is likely to fail through poor planning. No other intersection causes as much difficulty in planning or management as the intersection of change control, CAPA, document control and electronic systems.

Why should you Attend: CAPA and change control are consistently among the most common reasons for issuance of audit nonconformance reports. The intersection of Quality Systems elements can be compared to an intersection of streets. If the transition of traffic through the intersection is not well managed, the result can be damaging to all areas and parties involved. There are no clear recipes for managing QMS intersections. This is left for each company to interpret based on the nature of their products, services, customers, and applicable regulations. Additionally, while expectations for change control management are high, the specific requirements are scattered across various elements of the QMS regulations and standards, making it easy to misunderstand or misapply.

Where document control and records control requirements are defined within specific regulatory sections , making QMS procedural and process design simpler to implement; change control requirements are sprinkled throughout QMS areas including document control, records control, training, resource management validations, equipment controls, design controls,. process controls , purchasing, and supplier controls. Additional change control requirements may be found in non QMS regulations and standards, such as regulatory submissions management and adverse event reporting. Ineffective change control processes and records can easily result in incomplete changes, incomplete or ineffective training, ineffective or incomplete validations. The manufacture/ testing/ acceptance of product outside of approved regulatory submission documents can be a significant and costly impact of ineffective change control. The best solution is one of prevention-understand the full scope of change controls needed, and develop a stringent and well planned process for all change control interactions.

Areas Covered in the Session:
– Change control
– Regulatory Requirements
– Areas to consider and include in planning change control systems
– CAPA as a Feeder to Change Control
– CAPA as an Output of the Change Control System
– How to Develop Effective Interactions Between CAPA and Change Control
– Document Control
– Document Control as a Feeder to Change Control
– Document Control as an Output of the Change Control system
– How to Develop Effective Interactions between Document Control and Change Control
– Electronic Systems
– Electronic Systems as a Feeder to Change Control
– Electronic Systems as an Output of the Change Control system
– How to Develop Effective Interactions between Electronic Systems and Change Control Processes
– QMS Intersections
– How to Build and Maintain Effective Intersections Across QMS Elements
– How to Audit QMS Intersections

Who Will Benefit:
– Document Control Coordinators
– Quality Managers
– Production Managers
– Engineers
– Management Representatives

Deb Simpson has led development, implementation, and management of Quality Management Systems for regulated industry for more than 30 years. Deb has been involved with a variety of products and industry areas, including: 1. Medical Device, Pharmaceutical, Biologics, Tissue Banking, Medical electronics, Drug delivery devices, custom surgical convenience kits, Vet Med products. Combination products: Drug/Device/Biologics; Drug delivery devices. 2. Orthopedic implants, electronic monitors, medical textiles, respiratory inhalation systems; tracheostomy tubes, voice restoration products. surgical instruments, renal dialysis products; human and animal tissue processing and related products.

Deb is an experienced Quality System auditor and has served as Management Representative for several companies, including: Baxter Healthcare, Stinger Medical, Wright Medical, Regeneration Technologies, Bespak, Inc.