For pharmaceutical, medical
device and OTC companies, AccuReg offers guidance
and “hands on” support in the following critical
compliance areas:
- Quality Systems and compliance development and
implementation (including comprehensive Master Plans
for firms under consent decree and/or injunction)
- FDA 483 and Warning Letter responses and action
plans
- Comprehensive documentation and record-keeping
systems
- Development and review of individual compliance
documents, including Master Batch Records (MBRs),
Device Master Records (DMRs), Device History Records
(DHRs), Device History Files (DHFs), Standard
Operating Procedures (SOPs), Standard Test
Procedures (STPs)
- Development and implementation of complaint
handling systems
- Development and implementation of Corrective and
Preventive Action (CAPA) systems
- Design control process development, implementation
and training
- Business process re-engineering (BPR)
- Package design
- Process automation and control
- Process analysis/methods improvement
- Method and process validations
- Software and computer systems validations
- Production equipment procurement
- Product equipment relocation
- IQ/OQ/PQ of equipment and systems
- Development and implementation of Validation
Master Plans and validation SOPs
- QS Regulation, GMP, GLP and GCP training programs
for personnel at all levels
- Internal Audit and clinical audit training.
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