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Designing & Implementing GMP/QSR Compliant Quality Systems
The manufacturing and production operations related to chemicals and pharmaceuticals are often complex. Their success depends in part upon Quality Assurance/Quality Control procedures that ensure safety, maintain product standards and track adherence to government regulations. Emerging companies benefit from The Weinberg Group and our expertise in designing and implementing sound quality and compliance systems. We look beyond auditing to permanently correct compliance problems at their source. The following are some of the services we provide in this area:
- Design, develop and implement strategies to assure compliance with regulations
- Resolve compliance cGMP compliance assessments
- Develop and implement preventive strategies
- Establish sound quality systems based on Quality System Regulations (QSR)
- Deliver Quality System and Good Laboratory Practice audits, training and protocol development
- Use information compiled through interviews with company personnel to draft quality assurance manuals and Standard Operating Procedure documents
- Alert company officials to new guidance and compliance manuals from OSHA, EPA and other regulatory authorities
- Assessment and strategies to restore consumer confidence following product recalls and negative media exposure
- Develop Corrective Action and Preventive Action (CAPA) systems
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