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Please email your
queries on
training to
training@
avetalifesciences.com
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Training
Aveta has qualified experts in almost every field within the Regulated Life Sciences. Our professionals are well versed at both the hands-on execution of the work and the sustained training of that work to others. Our experts author books / technical papers and / or are frequent speakers at technical conferences worldwide. Their expertise spans the gamut of Lifesciences from extremely technical process equipment handling & maintenance, operational excellence and process validation to the compliance side of GMP integration, regulatory filings, design standards and lean adherence to the ever changing international requirements. Aveta approaches training from a practical day to day point of view to drive efficient process deep into the psyche of workers so that they are not only able to perform their function, but are fully integrated into the greater operational environment for maximum results that are competent, sustainable and compliant.
International Team of Alliance Partners:
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Most fields of the Regulated Life Sciences from early stage development and initial filings through Phase IV Pharmacovigilance. |
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Trainers with 15-40 years experience in industry |
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Regulatory & Compliance training by former FDA employees |
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Fred Rowley – Internationally known expert in solid dosage manufacturing. |
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Warford Reaney – Expert in GMP Compliance; GMP Integration; GMP Construction Management; Biopharmaceutical / Medical Device Program & Product Management. |
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Subject Matter Experts (SMEs) in Biotech, Pharmaceuticals, Parenterals, Medical Devices and Combination Products. |
On Site Hands-on Experience in Processing:
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Manufacturing: Biotech Upstream / Downstream Processing, Sterile Processing, Sustained Compliance, cGMPs, Quality Systems, P.A.T. |
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Process: Process Characterization, QbD, Tech Transfer, Scale Up, GMP Operational Processes. |
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Facility: Sterile Facility Design, GMP System Integration, Clean Utilities, Sterile Operations. |
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Validation: Cleaning, Process, Analytical Methods, Equipment & Environmental Monitoring, Risk Based Validation. |
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Compliance: Regulatory Filings, Inspection prep & Audit training with former FDA inspectors, Warning Letter remediation. |
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Computer Systems: Development, System Installation & Integration, Computer / Automation Validation including Electronic Batch Records, MES and risk based compliance related to 21CFR, Part 11. |
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Lab: GMP / GLP Lab operations, method development and method validation. |
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