About Celine Lam

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So far Celine Lam has created 55 blog entries.

Proven Data Integrity Practices for CQV: Ensuring Compliance in Equipment Qualification

Ensure data integrity during Commissioning, Qualification, and Validation (CQV) with proven practices from cGMP Consulting. Learn how we address FDA concerns, implement automated systems, and follow ALCOA+ principles to maintain data accuracy and compliance in equipment qualification.

2024-11-27T17:35:20+00:00October 17th, 2024|Commissioning, CQV, FUE, Industry Expertise|

The True Cost of Receiving an FDA 483: A Breakdown of Financial and Operational Risks

Uncover the financial and operational risks of an FDA 483, from costly remediation to reputation damage. Learn how cGMP Consulting can help mitigate these impacts and ensure compliance.

A Step-by-Step Guide to Equipment Qualification in a New Facility

Optimize your equipment for GMP compliance. Our guide covers equipment qualification steps to ensure performance, reliability, and regulatory standards.

2024-11-27T17:35:38+00:00October 10th, 2024|Commissioning, CQV, FUE, Industry Expertise|

Immediate Steps to Take After Receiving an FDA 483: Don’t Risk a Warning Letter

Learn the key steps to take after receiving an FDA 483 to avoid a Warning Letter, including swift response, CAPA plan development, and maintaining FDA communication.

Your Complete Guide to Audit Readiness: The 5 Step Process

Prepare your organization for success with cGMP Consulting's Audit Readiness Training. Our 5-step process equips your team to excel in regulatory inspections.

Understanding Commissioning, Qualification, and Validation (CQV): Ensuring Compliance in cGMP Environments

Learn about Commissioning, Qualification, and Validation (CQV) in cGMP environments to ensure compliance and product quality in the pharmaceutical industry.

2024-11-27T17:42:15+00:00October 1st, 2024|Commissioning, CQV, Industry Expertise|

Immediate Steps for MoCRA GMP Compliance: What Cosmetic Manufacturers Can Start Today

Prepare for MoCRA GMP compliance with cGMP Consulting. Get expert help with assessments, SOPs, and training for early compliance and reduced risks.

Your How-to Guide: Seamless Implementation of Electronic GMP Systems

Discover how to seamlessly implement electronic GMP systems with expert consulting from cGMP Consulting and amni.ai. Enhance compliance and operational efficiency in FDA-regulated industries.

Your Guide to MoCRA Compliance: The 6 Key Elements

Your essential guide to MoCRA compliance. Discover the latest regulations and steps to ensure your cosmetics meet FDA standards. Start preparing today!

Mastering GMP Certification: Your Ultimate Guide to Compliance Success

Master the GMP certification process with cGMP Consulting’s ultimate guide. Learn about our comprehensive evaluation, certification recommendations, and ongoing compliance support.

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