Program
|
Description |
DOCUMENT CONTROL
SYSTEM
|
Policy and SOP
Development, Review and Harmonization. Evaluate procedures in place and
develop a strategic plan to global procedures. Implement the
globalization plan by developing the procedures. Batch Record
development and review. Change Control review and action item closures.
|
INSPECTION READINESS
|
Design and Implement an Inspection
Readiness Program. Provide training to employees on inspection
readiness as well as train employees on effectively handling
inspections. Provide support in response to the FDA on 483 observations.
|
INTERNAL SYSTEM AUDITS
|
Support Quality’s internal audit
program by executing internal audits that are defined in the program.
|
DEVELOPMENT OF KEY PERFORMANCE
INDICATORS (KPIs)
|
Evaluate current systems and work
with the client to develop metrics to monitor the systems. Will use
statistical analysis to define targets and will implement corrective
actions to address non-compliance issues.
|
cGMP TRAINING
|
Provide cGMP
training to required personnel.
|
PHARMACEUTICAL
STABILITY PROGRAMS
|
Evaluate program
against current regulations in order to develop or enhance a Stability
program for final product, API, intermediates and raw materials.
|
DEVELOPMENT AND
ENHANCEMENT OF QUALITY SYSTEMS
|
Evaluate current
systems related to the six (6) FDA Inspection System. Will develop or
enhance the Quality system, Facilities & Equipment System,
Materials System, Production System, Packaging and Labeling System and
the Laboratory Control
System from a Quality Assurance perspective. Development of a Quality
System based on ICH Q10. Provide support to the customer’s Quality
Assurance team in performing Quality activities.
|
QUALITY CONTROL
PROGRAMS
|
Evaluate Quality
Control programs in the laboratory in order to assure compliance.
Develop and implement robust programs.
|
GLOBAL QUALITY
PROCESS HARMONIZATION
|
Develop and execute
strategic plans to harmonize the Quality System throughout the
organization.
|
ROOT CAUSE ANALYSIS
AND CAPA EFFECTIVENESS
|
Review of
investigations/deviations and CAPA’s. Provide training on root cause
analysis. Provide resourcing to close investigations and CAPA’s.
Develop and implement strong investigation and CAPA program.
|
SYSTEM VALIDATION
DOCUMENTATION REVIEW
|
Review and
Development of validation documents.
|
SUPPLIER/VENDOR
AUDITS
|
Perform
Supplier/Vendor audits to support Supplier program. Develop
Supplier/Vendor Qualification Program.
|
REGULATORY FILINGS
|
Review and write
Regulatory filings. Train employees on electronic filing with the FDA.
|
TRAINING
|
Provide Training on
Regulatory Guidance Documents.
|
RISK ASSESSMENT
|
Development of a
Risk Management program based on ICH Q9.
|
START-UP ACTIVITIES
|
Review /support of
design review documents and commissioning test plans.
|
