​(862) 701 - 6222

                                                            TOBACCO FDA READINESS

 

                                                                        GALANTE COMPLIANCE SERVICES, LLC

 

                                                                                                                                                                                     Regulatory Compliance & Quality Consulting Services for Regulated Industries

 

 

INTRODUCTION

Since 2009, FDA has regulated cigarettes, smokeless, and roll-your-own tobacco. The U.S. Food and Drug Administration recently finalized a rule that extends its regulatory authority to all tobacco products, including e-cigarettes, cigars, and hookah and pipe tobacco, as part of its goal to improve public health. Tobacco product manufacturers therefore, are preparing for issuance of the Tobacco Product Manufacturing Practices (TPMPs) which will guide the industry to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.

 

 

SERVICES

·       Quality Systems / GxPs Audits & Development

·       Compliance / Risk Assessments

·       Change Control / CAPA Systems Development

·       Policy & Procedures Development

·       Training

·       (FDA) Inspection Readiness Planning / Mock Audits

 

 

WEBINAR / SEMINAR / TRAINING OFFERINGS

·       How to Establish a Quality Program

·       Overview of FDA Regulations: Compare and Contrast cGMPS for Drugs to Draft Tobacco Product Manufacturing Practices (TPMPs)

·       How to Prepare for an FDA Inspection

·       Validation & 21 CFR Part 11