- Development of responses and implementation plan for regulatory agencies
- Remediation program design and execution
- Performance management of external resources
- Culture change
- Change management
- Laboratory remediation
- Product & process improvement and remediation
- Process understanding
- Process capability & control
- Drivers of product & process variability
- Regulatory Observations
- Warning Letter
- Consent Decree
- Suspension of operations
- Not-compliant status
- Distribution, Import, Export bans
A global pharmaceutical client operating under a Warning Letter, was having difficulty reviewing a significant deviations backlog for potential red flags that they suspected could further complicate their remediation effort.
- We deployed a team of six consultants to ‘work down’ a significant backlog (hundreds) of OOS and Deviations, with the primary goals:
- Quickly review the hundreds of documents to look for ‘red flags’ that could require escalation.
- Recommend remediation action to eliminate these red flag issues
- Further classify the backlog as amber and/or green to prioritize pre-FDA audit activity.
- Train internal OSS and deviation QA staff in proper root cause remediation on OSS and deviation investigation, close-out and reporting.
Both work streams were completed within 9 months, contributing to the lifting of the Warning Letter ahead of the anticipated timeframe.
Warning Letter Remediation
A global sterile injectable client operating under a Warning Letter, needed significant cross-functional support to meet remediation commitments, in addition to ongoing site expansion and corporate systems harmonization activities.
OQSIE deployed individual contributors and teams broadly across operations:
- Project Manager (1) supported the acquisition integration PMO
- Business Continuity Expert (1) supported gap assessment and execution of BCP integration activities to align with corporate processes
- EHS Expert supported remediation activities / commitments
- Industrial Engineers (2) supported new equipment implementation, e.g., visual inspection equipment and sitewide redesign of material and people flow
- Aseptic Process Supervisor (1) supported shop floor supervision of process & cleaning activities for improved quality compliance
- Aseptic Process Engineers (4) supported aseptic process assessments, identification and implementation of actions to reduce human error related issues
- Project Manager (1) and Tech Writer (1) supported a Supplier Quality Management initiative to align with corporate processes
- Validation Engineers (15) supported site expansion and remediation activities including,
- Installation, commissioning and qualification of Parts Washers
- Revalidation of all packaging and inspection lines
- Tech Writers (6) supported SOP & batch record revisions and alignment with corporate standards
All work streams were completed on-time, contributing to the lifting of the Warning Letter.
U.S. – Program Manager led PMO for remediation of 483 Observations.
U.S. – Sr. Program Manager organized and operationalized PMO for Warning Letter remediation program while client recruited PMO leader and team members, handed off a fully operational program to client employee.
Canada – Program Manager led PMO for Warning Letter remediation.
India – Program Manager led PMO for preparation for FDA audit.
U.S. – Four Project Managers led several work streams of Warning Letter remediation program.
Austria – Project Manager led remediation of training program.
U.S. – Subject Matter Expert guided remediation of Quality System gaps of pharmaceutical client’s transportation system
U.S. – Subject Matter Expert resolved complex CAPAs in the client’s cold chain distribution system.
U.S. – Team of Subject Matter Experts helped to reduce backlog of supplier audits and open CAPAs.
China – Subject Matter Expert supported API supplier audits ahead of critical product launch.
Brazil – Deployed Portuguese speaking team to perform comprehensive product documentation assessment for compliance gaps and lead gap remediation activity. Assessed and aligned site quality practices to both the corporate quality manual and ANVISA requirements.
**examples listed are representative, not an exhaustive list of projects OQSIE has supported**