Greetings
I'm Erwin Andrews, Principal Consultant and Owner of Andrews Professional Services, Co. I offer 20 years of Quality Systems and Aseptic Pharmaceutical Manufacturing leadership.
AbouT
Aseptic Manufacturing and Quality Systems
- Instructor for Aseptic Techniques for Isolators with SKAN US.
- Experienced performing Airflow Visualization Studies, Recording, Protocol generation, and Final reports.
- For major CDMO's implemented QA on the Shopfloor, for real time BRR. This improved batch release times by decreasing time for final record review by 3 days.
- For major CDMO's Improved Quality Systems to improve sites regulatory status from WarFning Letter and OAI to VAI status.
- Client facing Quality representative for CDMO project assessments. Ensure that new projects introduced to the facility meet quality system requirements.
- For a major CMO implemented OJTs for Aseptic Behavior techniques - Primary/Secondary operator, line set up, and lyo loading. This closed a gap for lack of training documentation for qualified operators.
- For a CDMO resolved issues with the media fill matrix. Company used the bracketed approach and some vial sizes were overlooked during media fills. Assessed the bracket and scheduled media fills to close the gaps identified.
- or a leading Vaccine manufacturer a new system for tracking of settle plates used for environmental monitoring. This system led to a 60% reduction in deviations caused by over exposed settle plates.
- For multiple major pharmaceutical companies improved aseptic manufacturing. This was achieved by improved QA oversight in response to FDA warning letters and Internal Audits.
What We Do
Commitment to Innovation
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Our company understands the technology and medicinal needs in the health care industry is consistently progressing. Our team of experienced professionals stay current about the latest drug trends.
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
We will work with companies of all sizes and product types. We maintain the highest level of professionalism and confidientiality when it comes to your company's processes, procedures, and products.
Knowledgeable
Pharmaceutical Manufacturing
Knowledgeable
With Andrews Professional Services our consultants maintain a working knowledge of industry standards. This is achieved by working with industry experts, attending conferences, and maintaining memberships to key organizations.