MQA Consulting Services
MQA provides consulting services to the Pharmaceutical, Biotechnology, Medical Devices and Nutritional product companies. MQA personnel and its associates have many years of experience in quality and microbiology to help resolve any microbiology and quality issues.
|
Click to review our services.
|
|
|
CONSULTING SERVICES
-
Facility review and validation
-
Critical utilities review and validation
-
Microbial control program design
-
Quality systems review and design
-
GMP audits - in-house or external
-
Raw material program design
-
Quality Control systems review and design
-
Validation protocol preparation and executions
-
Facility preparation for FDA or EU inspections or PAI
-
Microbial, media fill and sterility failure investigations
-
Clean room and fill room design and evaluation
-
Media fill program design
|
|
|
|
|
Consultants
|
 |
Juan Munoz
|
|
|
Consulting areas:
|
|
|
|
microbiology, environmental monitoring, training, validation, sterilization, clean rooms, QC and QA systems
|
|
|
|
Summary of professional experience:
|
|
|
|
|
25 years experience in microbiology, quality, compliance and validation.
|
|
|
Expert knowledge of clean rooms operation and validation.
|
|
|
Expert knowledge in microbiology procedures (USP, CFR, FDA, EU, AAMI, AOAC and Std. Methods for Water Testing).
|
|
|
Expert knowledge of environmental monitoring requirements.
|
|
|
Expert knowledge of QC and QA operations.
|
|
|
Experience validating QC lab equipment, facilities, critical utilities, QC methods such as TOC, LAL, bioburden and other methods.
|
|
|
Project management experience.
|
|
|
Bilingual: English and Spanish
|
|
|
|
|
|
|
Jesse Ayala - MQA Associate
|
|
|
Consulting areas:
|
|
|
|
aseptic filling processes, filling equipment procurement, factory acceptance testing, clean room operations, batch record preparation, and validation of aseptic processes.
|
|
|
|
Summary of professional experience:
|
|
|
|
|
24 years experience in FDA and GMP regulated environments.
|
|
|
Expert knowledge of aseptic processes.
|
|
|
Knowledge of FDA and EU environmental monitoring requirements.
|
|
|
Experience preparing microbiology and environmental monitoring investigations and EM reports.
|
|
|
|
|
|
|
Geoff Weiss - MQA Associate
|
|
|
Consulting areas:
|
|
|
|
biotechnology process development for recombinant proteins and enzymes, protein purification column packing services, purification equipment selection and procurement, chromatography column life cycle studies and general purification process consulting.
|
|
|
|
Summary of professional experience:
|
|
|
|
|
Over 20 years experience in biotechnology protein purification.
|
|
|
Expert in protein purification process design
|
|
|
Expert knowledge of GE AKTA purification systems
|
|
|
Expert knowledge on chromatography column packing from lab scale to manufacturing scale.
|
|
|
Expert knowledge of chromatography processes
|
|
|
|