About Us

QARA Navigator is a collaborative platform that brings together subject matter experts from various areas of the (bio) pharmaceutical and medtech industries. We are here to consolidate and freely share the valuable knowledge and xperience acquired throughout our individual professional paths. We don’t just talk in generalities; we delve deep into the topic, so you can be sure to find the right  nswers here. Target, focus, and diligence are the pillars of our collaborative work. QARA Navigator is here to assist you throughout your professional journey.


GMP (Good Manufacturing Practices)

Navigate here for the recent cGMP news and updates in the US, Canada, and Europe. Find specific GMP-related topic
to get an expert in-depth analysis.

1.  Three FDA Warning Letters due to Unanswered Requests for Records 
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2. CDER Quality Management Maturity 
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Validation and Qualification

Navigate here for a detailed and focused discussion of critical aspects to conduct successful and compliant validation
and qualification studies.

1. Process Validation.
Download and insert the full document Final Guidance Document

2. Process Validation and ICH Q7
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Aseptic Manufacturing & Sterile Dosage Forms
Navigate here to obtain an in-depth understanding of the important components that are required for GMP-compliant aseptic manufacturing operations, including cleanrooms, environmental onitoring, facility and utilities management, equipment design and many more.

Annex 1

Health Canada updates Annex 1 to the Good Manufacturing Practices Guide – Manufacture of Sterile Drugs (GUI-0119) to harmonize it with the requirements of EU Annex 1, Manufacture of Sterile Products

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Informative discussion

Informative discussion by the members of the ISPE Boston Area Chapter on Cleanroom Environmental Monitoring and Contamination Control 

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  • Health Canada announces the forward regulatory plan 2023-2025: Regulations amending the Natural Health Products and the Food and Drug Regulations (Self-Care Framework)

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    In September 2023, FDA released a final guidance entitled, “Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.” Under section 506B of the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations at 21 CFR 314.81(b)(2)(vii) and 601.70, drug and biologics sponsors must submit an annual report to FDA providing the description, schedule, and status of their postmarketing requirements and commitments (PMR and PMC). This final guidance, which closely mirrors FDA’s 2018 draft guidance document, outlines recommendations for completing and submitting reports – specifically, through Forms FDA 3988 and 3989 – which may relate to PMR/PMC studies or clinical trials concerning a product’s clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology.

  • On September 18, 2023, FDA issued a draft guidance, titled, “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance describes how FDA intends to apply its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a combination product. FDA intends to consider several factors when determining whether the end-user output should be regulated as FDA-required labeling or promotional labeling. Factors include (1) whether the prescription drug use-related software provides a function that is essential to the safe and effective use of the product, (2) whether evidence is provided to support a clinical benefit when the prescription drug use-related software is used, and (3) whether the prescription drug use-related software relies on data directly transferred from the device constituent part of a combination product.

Our Team

Oksana Nedostup

Oksana has more than 15 years of experience in pharmaceutical and medical devices industries. Oksana started her professional path as Quality Assurance Engineer in clinical trials logistics services for large pharma companies. She then continued her career as a supervisor of aseptic filling operations at a Canadian CMO. For the past seven years, Oksana has been working in Quality Assurance and Regulatory Affairs ensuring consistent implementation of Quality Management Systems in the manufacturing operations of pharmaceuticals and medical devices as well as ensuring diligent application of regulatory intelligence throughout the product lifecycle.

Talks about:
QMS, cGMP, FDA, Health Canada, internal audit, GMP Inspection, supplier management, CAPA, Change Control, Pharmacovigilance, ISO 13485:2016/MDSAP, laboratory controls, OOS Investigation, Root Cause analysis, Risk Management.

Masha Ivankovic, Ing.

Masha has more than twelve years of experience in the pharmaceutical and biotechnology industries in Canada, United States, and Europe. Having started her career as Validation Specialist in the injectable pharmaceuticals industry, she pursued her path as a consultant. This allowed her to cover a large spectrum of mandates in engineering, validation, and project management in the life sciences industry. Masha has earned her Bachelor of Sciences degree at McGill University, Bachelor of Chemical Engineering at the Polytechnique Montreal, and an MBA at McGill University. Masha is also a member of the Order of Engineers of Quebec.

Talks about:
validation and qualification (equipment, utilities, and process), project management, computer systems validation

Contact Ua

Our Address

Canada, Toronto, Ontario

Our Email


Out Phone

(514) 692-0662