Deepthi Datla
Quality Assurance Specialist at Leica Microsystems | Buffalo Grove, Illinois, United States
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Deepthi Datla is a seasoned Quality Assurance Specialist at Leica Microsystems, where she leverages her extensive background in regulatory affairs to ensure compliance with stringent industry standards. With a Master’s degree focused on Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, Deepthi brings a wealth of knowledge to her role, particularly in navigating the complexities of FDA regulations and quality management systems as outlined in 21 CFR 820.
In her current position, Deepthi plays a pivotal role in coordinating field corrective actions and recalls across North America, ensuring that all processes align with regulatory requirements. Her expertise in adverse event reporting for Health Canada and the FDA as an importer underscores her commitment to patient safety and product efficacy. Additionally, she oversees the maintenance of ISO/IEC 17025 certification, which is critical for laboratories involved in testing and calibration, further solidifying her role in upholding quality standards within the organization.
Deepthi is also instrumental in the review and approval of promotional and marketing materials, ensuring that all communications comply with regulatory guidelines while effectively conveying the value of Leica Microsystems’ innovative products. Her experience in assisting both internal and external audits demonstrates her meticulous attention to detail and her ability to foster a culture of compliance within the organization. With a strong foundation in the pharmaceutical industry and a keen understanding of the commercialization process for biomedical products, Deepthi Datla is a valuable asset to Leica Microsystems, driving quality assurance initiatives that enhance product integrity and regulatory adherence.
Quality Assurance Specialist at Leica Microsystems in October 2021 to Present
Regulatory and Scientific affairs at Base10 Genetics in January 2021 to October 2021
Senior Regulatory Compliance Analyst (Office of Research Integrity ) at Spectrum Health in April 2018 to September 2019
Regulatory Affairs Analyst (IRB) at Spectrum Health in November 2015 to March 2018
Scientific Team Member at Rare Genomics Institute in May 2015 to September 2016
Regulatory Affairs Associate at Chalfont Research Institute in March 2015 to October 2015
Formulations Research Trainee at Mylan Laboratories Limited in October 2010 to April 2011
Summer Research Intern at Aizant Drug Research Solutions Pvt. Ltd., Hyderabad in May 2008 to June 2008
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Northeastern University, Masters, June 2026
Sri Ramachandra Medical College and Research Institute, Masters of Pharmaceutics, June 2026
Sri Ramachandra Medical College and Research Institute, Bachelor of Pharmacy (B.Pharm.), June 2026
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Regulatory Requirements
Attention to Detail
Quality Assurance
Pharmaceutical Industry
Regulatory Affairs
Formulation
Pharmaceutics
GMP
Regulatory Submissions
Drug Delivery
Medical Devices
SOP
Clinical Trials
Pharmaceutical Research
ANDA
GLP
Microsoft Office
Pharmacokinetics
CAPA
45 CFR 46
Medical Device regulations
IND
NDA
21 CFR 312
21 CFR 314
21 CFR 58
21 CFR 11
21 CFR 820
21 CFR 210
21 CFR 211
Market assessment and research methodologies
Forecasting, pricing, reimbursement, Budgeting
Role of marketing and sales in commercialization process of biomedical products.
Documentation
21 CFR 50
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
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Discover more about Leica MicrosystemsWhat is Deepthi Datla email address?
Email Deepthi Datla at [email protected] and [email protected]. This email is the most updated Deepthi Datla's email found in 2026.
What is Deepthi Datla phone number?
Deepthi Datla phone number is 3373044626.
How to contact Deepthi Datla?
To contact Deepthi Datla send an email to [email protected] or [email protected]. If you want to call Deepthi Datla try calling on 3373044626. (updated on August 25, 2024)
What company does Deepthi Datla work for?
Deepthi Datla works for Leica Microsystems
What is Deepthi Datla's role at Leica Microsystems?
Deepthi Datla is Quality Assurance Specialist
What industry does Deepthi Datla work in?
Deepthi Datla works in the Health, Wellness & Fitness industry.
Deepthi Datla Email Addresses
Deepthi Datla Phone Numbers
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