Services

CONTACT CENTERS

Bio/Pharma ~ Medical Devices ~ Health & Beauty ~ Food

GALANTE COMPLIANCE SERVICES, LLC

Regulatory Compliance & Quality Consulting Services for Regulated Industries

SERVICES

·  (FDA) Inspection Readiness Planning / Mock Audits

·  Product Recalls Planning

·  Metrics and Dashboard Design

·  Computer Systems Validation and Electronic Records & Signatures (21 CFR Part 11) Assessment

·  Data Security & Privacy Audits

·  Validation Strategy / Document Review

·  Policy & Procedures Development

·  Training

·  Compliance / Risk Assessments

·  Third Party Management: RFP Process, document review, on-site overview, Quality Agreements/SLAs/Contracts

·  Project Management

·  Crisis Management / Business Continuity Planning

·  Change Control / CAPA Systems Development

·  Quality Systems / GxPs Audits & Development

·  Six Sigma Process Excellence / Process Mapping

·  Benchmarking

WEBINAR / SEMINAR / TRAINING OFFERINGS

·  How to Prepare for an FDA Inspection

·  Overview of FDA Regulations for Pharmaceuticals, Medical Devices, Health & Beauty and/or Food

·  How to Establish a Quality Program for Your Contact Center

·  Adverse Event Reporting: What You Need To Know

·  Validation & 21 CFR Part 11

·  Product Recall Preparedness: Lessons Learned

HEALTHCARE

Hospitals ~ Clinics ~ Ambulatory Care Centers

GALANTE COMPLIANCE SERVICES, LLC

Regulatory Compliance & Quality Consulting Services for Regulated Industries

SERVICES

·  Data Security & Privacy Audits

·  Policy & Procedures Development

·  Training

·  Compliance / Risk Assessments

·  Crisis Management / Business Continuity Planning

·  Metrics and Dashboard Design

·  Quality Systems / GxPs Audits & Development 

·  Change Control / Corrective Action Preventative Action Systems Development

·  Computer Systems Validation and Electronic Records & Signatures (21 CFR Part 11) Assessment

·  Project Management

·  Six Sigma Process Excellence / Process Mapping

WEBINAR / SEMINAR / TRAINING OFFERINGS

·  HIPAA Compliance

·  Data Security & Privacy: How To Protect Patient Information

·  Aseptic Handling: How To Apply These Principles To The Hospital Environment

MANUFACTURING/PACKAGING

Bio/Pharma ~ Medical Devices ~ Health & Beauty ~ Food

GALANTE COMPLIANCE SERVICES, LLC

Regulatory Compliance & Quality Consulting Services for Regulated Industries

SERVICES

·  Validation: Process, Cleaning, Utilities

·  Equipment Qualification

·  Computer Systems Validation and Electronic Records & Signatures (21 CFR Part 11) Assessment

·  Validation Strategy / Document Review

·  Six Sigma Process Excellence / Process Mapping

·  Compliance / Risk Assessments

·  Third Party Management: document review, on-site overview, Quality Agreements/SLAs/Contracts

·  ISO Certification

·  (FDA) Inspection Readiness Planning / Mock Audits

·  Project Management

·  Business Continuity Planning

·  Change Control / CAPA Systems Development

·  Quality Systems / GxPs Audits & Development 

·  Policy & Procedures Development

·  Training

WEBINAR / SEMINAR / TRAINING OFFERINGS

·  Webinar on How to Prepare for an FDA Inspection

·  Seminar on Drug Quality Security Act: How Does It Affect You?

·  Webinar on Cleaning Validation at a Contract Manufacturer or Packager

·  Training Seminar on Overview and History of FDA and Validation

PROJECT MANAGEMENT

Bio/Pharma ~ Medical Devices ~ Health & Beauty ~ Food

Hospitals ~ Clinics ~ Ambulatory Care Centers

GALANTE COMPLIANCE SERVICES, LLC

Regulatory Compliance & Quality Consulting Services for Regulated Industries

INTRODUCTION

Project Management is the practice of overseeing a specific project with a defined beginning and end.  It includes initiating, planning, executing, controlling, and completing the work of a team to achieve specific goals and meet specific success criteria. A project plan is developed by the Project Manager which includes defining the project milestones, identifying tasks and timing for each task, quantifying the resources needed, and determining timelines for completion. It also includes managing the implementation of the project plan, organizing team meetings and ensuring the team stays on track. Periodic reports are issued to Management identifying any obstacles or constraints that may delay the timely completion of the project.

SUPPORTING SERVICES

·  Six Sigma Process Excellence / Process Mapping

·  Metrics and Dashboard Design

·  Compliance / Risk Assessments

·  Policy & Procedures Development

·  Training

SIX SIGMA / LEAN

Bio/Pharma ~ Medical Devices ~ Health & Beauty ~ Food

Hospitals ~ Clinics ~ Ambulatory Care Centers

GALANTE COMPLIANCE SERVICES, LLC

 Regulatory Compliance & Quality Consulting Services for Regulated Industries

INTRODUCTION

Do you want to be more efficient, increase productivity and reduce costs? Six Sigma is a methodology that uses statistical techniques and tools to analyze, develop/plan and implement improvement changes that result in reduced process cycle time, reduced costs, increased customer satisfaction, and increased profits. Lean is a methodology focused on reducing waste. Six Sigma seeks to improve the quality of the output of a process by identifying and removing the causes of defects and minimizing variability in manufacturing and business processes1. This is accomplished through the use of two Six Sigma sub-methodologies: DMAIC and DMADV. The Six Sigma DMAIC process (define, measure, analyze, improve, control) is an improvement system for existing processes falling below specification and looking for incremental improvement. The Six Sigma DMADV process (define, measure, analyze, design, verify) is an improvement system used to develop new processes or products at Six Sigma quality levels. Both Six Sigma processes are executed by Six Sigma Green Belts and Six Sigma Black Belts, and are overseen by Six Sigma Master Black Belts2.

SUPPORTING SERVICES

·  Process Mapping

·  Project Management

·  Metrics and Dashboard Design

·  Compliance / Risk Assessments

·  Policy & Procedures Development

·  Training

REFERENCES

1 https://en.wikipedia.org/wiki/Six_Sigma

2 http://www.isixsigma.com/new-to-six-sigma/getting-started/what-six-sigma/

DATA SECURITY & PRIVACY

Bio/Pharma ~ Medical Devices ~ Health & Beauty ~ Food

Hospitals ~ Clinics ~ Ambulatory Care Centers

GALANTE COMPLIANCE SERVICES, LLC

Regulatory Compliance & Quality Consulting Services for Regulated Industries

INTRODUCTION

Cyber security threats are growing at a rapid pace. Hackers are designing malware that covers its tracks so detection becomes even more difficult. Businesses not only need a cyber security strategy to protect their data and customer information, but they need to focus on early detection of breaches as well as what to do when a breach occurs. A Data Breach Response Plan will do just that. It is necessary to investigate and implement technology solutions, policies and procedures that manage, control and protect against threats or hazards to security or integrity of data, uses or disclosures of protected health information and ensures education and compliance of the workforce.

SERVICES

· Data Security & Privacy Audits / System Vulnerabilities Assessment

· Information Security Program Development

· Privacy Policy Development

· Data Management, Retention & Destruction Policies Development

· Training

· Crisis Management / Business Continuity Planning

· Data Breach Response Plan

· Third Party Audits/Due Diligence

· Computer Systems Validation and Electronic Records & Signatures (21 CFR Part 11) Assessment

WEBINAR / SEMINAR / TRAINING OFFERINGS

· HIPAA Compliance

· Data Security & Privacy: How To Protect Patient Information