Nonconformance Posts

Deviation Management and the Next Level of GMP Compliance

Deviation Management and the Next Level of GMP Compliance

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

Despite the best efforts of industry and regulators alike, quality issues are on the rise. Product complaints are up, along with product recalls, drug shortages, product bans, plant shutdowns, and enforcement actions. This means that industry and regulators alike are looking for answers.

Fortunately, many of these answers lie within your existing deviation management processes and data. The key is understanding the true driver behind Good Manufacturing Practices (GMP), and then structuring your deviation and quality management processes accordingly.
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Unannounced Regulatory Audits Hitting Global Med Device Community

Unannounced Regulatory Audits Hitting Global Med Device Community

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

No one likes to be caught off-guard. Have you ever had a contractor show up at your home before you’ve even woken up? Or your child tells you he needs his original birth certificate the very next morning to register for camp. These facts of life often arise when you least expect it. (more…)