Outsourcing and Offshoring in a New Era of FDA Enforcement

Jack Garvey |

On Thursday, March 11, 2010, Jack Garvey, Principal, Compliance Architects LLC, will be presenting an audio conference in conjunction with FXTranslations  and FXConferences entitled "Outsourcing and Offshoring in a New Era of FDA Enforcement."    This audio conference will... Read more

Regulatory Alert: New FDA Proposed Rule — Sponsor Reporting of Falsified Data

Jack Garvey |

Today the FDA has published a proposed rule in the Federal Register (75 FR 33 at 7412, 2/19/10) that will require sponsors (and defining petitioners under food/supplement submission rules as sponsors) to report to FDA any instance of... Read more

Implementing an FDA-Regulated Quality System Using Microsoft SharePoint®

Jack Garvey |

New Jersey based pharmaceutical and medical device companies have a great opportunity this month to gain some significant information on how to improve their compliance outcomes and reduce their costs, using Sharepoint-based quality systems.    Sharepoint has become a... Read more