Biosketch
Rachel Monsef
Rachel Monsef is an analytical chemist in the pharmaceutical industry who has 16 years’ experience working in Analytical and Quality Control for all stages of drug development. She has been responsible for method development, method qualification, method validations, assay transfer, characterization work, and stability studies. Ensuring GMP compliance with data integrity has always been within the realm of these responsibilities. She has used many different software interfaces and data storage systems that had to comply with 21CFR11. Through her consulting she has gained much experience with remote data review ensuring that data integrity is present for her client. She has previously worked for Seattle Genetics and Alder Biopharmaceuticals. She is currently a Quality Control Consultant at Alder Biopharmaceuticals.
Education
University of Was
hington; Seattle, WA
- Bachelor of Science in Chemistry
- Graduated with Honors
- Undergraduate Research
Relevant Training Courses
- Instrumental and quantitative analysis
- Transition Methods
- Spectroscopy Identification
- Stability Programs from Development to Approval
- Capillary Electrophoresis for Bio-molecules
- HPLC Analysis and Purification of Proteins and Peptides
Experience Prior to Monsef Consulting
Alder Biopharmaceuticals, Bothell, WA
- Senior Research Associate
- Analytical and Formulation Group
Nastech Pharmaceuticals, Bothell, WA
- Research Associate
- Quality Method Development Group
- Quality Control Associate
Sonus Pharmaceuticals, Bothell, WA
- Quality Control Associate
Full resume and references available upon request
Upcoming Courses
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On Demand Courses
“In recent years,” states the Agency, “FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.” This intensive 90-minute accredited online training course focuses on how you can look for, assess, and correct possible Data Integrity issues at your firm, and demonstrate to FDA that your CGMP data are ALCOA (attributable, legible, contemporaneously-recorded, original or a true copy, accurate). The centerpiece of our discussions will be a new Draft Guidance for Industry published by FDA which expresses the Agency’s current thinking on this crucial subject.
This 90-minute accredited course will help any new user get started by giving practical information on HPLC theory, its many modes of operation and how to ensure that the analysis and the HPLC are working properly. New HPLC users who take this course will be empowered with the tools they need to get a solid start using this analytical tool with its many valuable and versatile analytical uses.
This basic HPLC course will benefit the personnel with some HPLC experience who are developing or optimizing HPLC methods. This 90-minute accredited course will include discussions of theory of Reversed and Normal Phase, Ion Pairing and Ion-Exchange Methods. It will also give basic starting points on method development and method evaluation. The course is designed to give personnel with some HPLC experience a broader scope for how to use this invaluable analytical tool.
This online training will be most useful for people with some analytical experience who are interested in broadening their understanding of characterization methods of Proteins and Peptides: Biopharmaceuticals, food sciences or any other industry analyzing proteins would be of interest.
The potential job functions would be entry to mid-level laboratory personnel with some lab experience, or laboratory personnel with degrees in other disciplines who need to understand protein and peptide characterization.
The departments in companies involved with molecule characterization, Quality Control, Quality Assurance, Analytical Scientist, Research Associates, Engineers and Administrators working in analytical development, Product Development, Manufacturing, Validation, Formulation, and Pre-formulation groups would benefit from this training.
Recent Articles
Data Integrity: A new FDA draft Guidance
I want to speak to the heart of the matter of data integrity, because I think that it will be of help to folks when setting up related systems or attempting to improve them. The purpose of data integrity controls is to make sure that each assay or procedure can...
Why a Consultant?
In the Pharmaceutical industry, consultants can be very useful in many areas. They can be used for auditing, implementing new technologies, training, or even setting up new systems and software. However, the extent of consultant work can reach far beyond those...
Ultra-Performance Liquid Chromatography
There has been a lot of chatter over the last few years about Ultra Performance Liquid Chromatography (UPLC) instruments. Whenever new technologies come out, two things usually happen: The analytical development groups are instantly writing up purchase orders and...
Work with Rachel
My job is to help the analytical programs at your pharmaceutical company, from method development all the way through validation of your methods. Let me develop a training program specifically for your company's needs. Get in touch with me and we can start working today.