Baron Environmental attended the most recent New Jersey Pharmaceutical Association for Science and Technology (NJPhAST) conference on 12/1/22 in Washington Township, NJ. The mission of NJPhAST, formerly the NJ Pharmaceutical Discussion Group, is to provide a forum for discussion, continuing education and the exchange of ideas on advances in Pharmaceutical Sciences and Technology. NJPhAST is northern-NJ based, and conducts monthly meetings.
Our involvement with the NJPhAST non-profit organization aligns with our company's ongoing outreach "to remove the overload of burdensome environmental and health & safety regulations for Pharmaceutical Manufacturing, Life Sciences, Cosmetics, Flavor & Fragrance and other product manufacturers".
The presenter, CDR Chad N. Thompson, Director of Investigations Branch in the Office of Pharmaceutical Quality Operations Division of the Food and Drug Administration (FDA) spoke on “Revised Compliance Program 7346.832 – Pre-Approval Inspections”. He provided an overview of the USFDA pre-approval inspection compliance program 7346.832 applied during pre-approval inspection coverage and highlighted the recent revision made effective on October 17, 2022. The revision added elements of the ICH guidance for industry, impurity risk assessment and the use of alternative tools in lieu of and in advance of inspections. Fundamental knowledge of this compliance program will aid in the preparation of pre-approval inspections.
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We Use Scrum For Your Benefit. ®
The Baron Environmental team-based approach makes environmental, health & safety compliance simple, efficient, and stress-free for people within pharmaceutical manufacturing, life sciences, and other product manufacturing industries. What distinguishes ourselves from all others is our Scrum process framework that delivers Twice the Work in Half the Time. See for yourself how we streamline burdensome regulatory requirements that many companies often face alone.
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