REMOTE SERVICES
Isha’s GMP is supporting our clients with the same expertise, knowledge, and partnership you experienced before “social distancing” became the most spoke phrase in the English Language. All our people, capabilities, and resources are fully engaged when our clients need them most; that time is now.
ALL OF OUR SERVICES. ALL OF THE TIME.
We have been working with clients onsite and remotely. And today, it is more important than ever to collaborate in new and innovative ways. Isha’s GMP is fully staffed and prepared to help you remotely now and into the future.
Current Remote Service Offerings Include:
- Quality Systems Implementation and Remediation
- Policy, Standard, SOP writing
- Due Diligence Assessments
- CAPA plan reviews
- Investigation reviews and writing
- Batch record reviews for product disposition
- Audits (Internal and Supplier) done virtually through technology
- Facility Design Reviews
- Data Integrity Reviews – Lab and Manufacturing
- Cross contamination assessments
- Environmental monitoring assessments
- Environmental monitoring excursion assessments
- Training
- Annual GMP Training and certification
- 483 and Warning Letter Responses
- Supplier Quality Management
- Quality Agreements
- Management Controls implementation
- Device Design History Files
- Analytical Method Review
- Strategies for conducting manufacturing activities with only essential personnel
- Design of Quality Organization for sustainable compliance