Advantages
The Benefits of working with Monsef Consulting include:
Working directly with Rachel Monsef who has 16+ years of industry experience with Biopharmaceutical methodology and GMP regulations.
Phase appropriate strategy for your analytical program. Whether you are just starting to develop a product, or your company is preparing for commercial stage 4, I will help design a strategy for your analytical program ensuring compliance with FDA and ICH guidelines.
Full Analytical services. Analytical programs take a lot of attention to detail in several areas, I can offer an array of services: method development guidance, optimizing methods, method qualification and validation, lab system design, stability program design, document writing and meticulous data review.
On-Site Training: Rachel Monsef can also provide on-site training for many GMP and analytical topics. Below are links to upcoming training courses or courses available online. If you need training in other areas, this can be developed specifically for your company.
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.
Upcoming Courses
There are no upcoming events.
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 The centerpiece of our discussions will be a new Draft Guidance for Industry published by FDA which expresses the Agency’s current thinking on this crucial subject.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
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