Remote Inspections: How to Navigate the Expectations

The webinar was successfully concluded on

November 09, 2023

Topics Covered:

Understanding remote inspections.
Navigating the digital landscape.
Preparing for a successful remote inspection.
Success stories.

As a continuous practice, Freyr intends to organize webinar sessions related to the Regulatory aspect of the Life Sciences industry. We believe you would like to be a part of all those sessions. If yes, we will be happy to inform you in advance about our next session.

Martynas Gulbinas is a Delivery Owner specializing in medicinal products at Freyr. With a background in Biological Sciences and extensive experience in Regulatory affairs, Martynas successfully manages high-growth accounts within the EUA region, ensuring the successful fulfillment of client goals and requirements.

Rajni is a seasoned pharmaceutical Regulatory, quality & compliance expert with over 30 years of versatile industry exposure. Her extensive background spans API research, employing a quality-by-design methodology for technology transfer and scale-up operations. She has proficiencies in international Regulatory Affairs, compliance, and corporate quality assurance, having triumphed in numerous global audits/inspections.

Rajni's influence extends to advisory roles, benefiting multiple pharma firms with her Regulatory and quality insights. Furthermore, her adeptness in GMP audits solidifies her position as a comprehensive industry resource.

Hosted By

Martynas Gulbinas

Presented By

Rajni Jha

Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.

The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.