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Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference

FDA Law Blog

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. By John W.M. Truly, these are complex considerations.

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Beginner’s Guide to 21 CFR Part 11 Compliance

Advarra

This applies to electronic data and signatures submitted under records requirements under other regulations such as: Federal Food, Drug, and Cosmetic Act. After platform review, if a decision is made to validate, staff should generate documentation to ensure Part 11 compliance. Public Health Service Act.

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In the News: October 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Batch steps include filter drying, milling, and packaging. FDA Guidance Addresses Real-World Evidence Data Standards.

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HP&M is Pleased to Welcome Lisa Baumhardt (Senior Medical Device Regulation Expert) and Sophia Gaulkin (Associate) to the Firm

FDA Law Blog

Baumhardt develops regulatory strategies, prepares pre-submissions and regulatory market authorization submissions, drafts regulatory policies and procedures, and reviews advertising and promotional materials. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters.

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Accelerating Consumer Product Research with Unified Clinical Trial Management Solutions

Cloudbyz

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The trials span several categories of consumer products such as cosmetics, personal care products, nutrition supplements, food, beverages, and consumer health products.

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25 Reasons Why Pharmaceutical Companies Need a Unified Clinical Trial Management Platform

Cloudbyz

The pharmaceutical industry plays a critical role in improving healthcare by developing and bringing new medicines to market. Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount.

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New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. About the authors.