Chapter 1

The Challenge



In 2016, a top-10 international pharmaceutical manufacturer faced a seemingly insurmountable goal of implementing a comprehensive training program for non-technical staff, covering everything from GDP to aseptic processing. The industry giant elicited more than 20 proposals for a comprehensive solution with a demanding timeline of four months. 

With an expert trifecta—Azzur Southeast, Azzur Labs, & Learnaboutgmp—Azzur Group presented a single-source solution unmatched by the competition.
 
Azzur Labs


Azzur has active Part 11 participation with PDA, ISPE, GAMP, IVT and ASQ, and our project portfolio includes more than 350 Part 11 projects. We advise and contribute regulatory solutions on Part 11, CAPA, and Risk-Based Approaches to compliance through participation in committees, tasks groups, conferences, and published paper, as Part 11 guidelines continue to develop.

At Azzur, we work together closely to help our customers succeed through documented evidence of the fulfillment of qualification and validation protocols. Our bottom line is helping our customers meet the precise standards of the DEA, EMA, and FDA.

Our validation subject matter experts have a proven process that includes documentation and auditing to provide  a high-degree of certainty that their process consistently produces results and products that achieve the predetermined quality and specifications. Each Azzur team member has the technical expertise specific to the industries we serve to ensure your complex projects are completed thoroughly and quickly.
In your opinion, how prepared is your team to handle unexpected GDP challenges?:
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