About Celine Lam

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So far Celine Lam has created 52 blog entries.

A Comprehensive Guide to Good Manufacturing Practices (GMP)

Learn everything about Good Manufacturing Practices (GMP) in this comprehensive guide. Discover the 10 key elements of GMP, the GMP process, best practices for compliance, and insights into FDA inspections to ensure quality and regulatory adherence.

2024-11-22T19:52:32+00:00November 21st, 2024|Industry Expertise, LinkedIn|

Success Story: Resolving an FDA Warning Letter for a Food & OTC Manufacturer

Discover how we helped a food & OTC manufacturer successfully resolve an FDA Warning Letter with a comprehensive compliance strategy and corrective.

2024-11-18T18:04:33+00:00November 18th, 2024|Industry Expertise, LinkedIn|

Avoiding Common FDA 483 Observations: An Industry-Specific Compliance Guide

Discover how to avoid common FDA 483 observations with industry-specific best practices. Enhance your regulatory compliance efforts today with expert insights from cGMP Consulting.

2024-11-22T14:58:54+00:00November 6th, 2024|Industry Expertise, Audits, LinkedIn|

Why Equipment Requalification is Just as Important as Equipment Qualification for FDA Compliance

Discover why equipment requalification is as crucial as initial equipment qualification for FDA compliance. It ensures ongoing regulatory adherence, reliability, and product quality while minimizing risks.

2024-11-05T23:00:39+00:00October 31st, 2024|Industry Expertise, LinkedIn|

How to Qualify Sterile Fill Line Equipment: Key Steps and Best Practices for Compliance

Discover key steps for equipment qualification of sterile fill line equipment, ensuring FDA compliance with best practices from installation to performance qualification.

2024-11-05T23:01:52+00:00October 23rd, 2024|Industry Expertise, LinkedIn|

Driving Continuous Improvement in FDA-Regulated Industries: Strategies to Prevent FDA 483 Issues

Prevent FDA 483 issues with expert strategies in compliance, data integrity, and quality systems from cGMP Consulting.

2024-11-05T23:05:30+00:00October 21st, 2024|Industry Expertise, Audits, LinkedIn|

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.

2024-11-05T23:09:06+00:00October 17th, 2024|Industry Expertise, LinkedIn|

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.

2024-11-05T23:09:37+00:00October 14th, 2024|Industry Expertise, Audits, LinkedIn|
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