Areas Covered:

Areas Covered:

Areas Covered:

Areas Covered:

Audit Techniques of a FDA Auditors

1. FDA Current Audit Techniques
2. Types of Operator Errors
3. Risk Based Approach

Quality Control System Components

1. Quality System & Phases
2. Facility and Equipment Systems
3. Production and Materials System
4. Laboratory Control Measures
5. Packaging and Labeling Systems

How to Address FDA 483 Observations

1. Best Practices to Address 483
2. 10 Most Common GMP Drug Deficiencies

Areas Covered:

FDA GMP Requirements for Raw Material Management

1. GMP and Raw Material
2. Raw Material Regulations
3. Ensuring Good Quality Raw Materials
4. Good Documentation Practices
5. Common Issues with Compliance

Vendor Selection and Validation Requirements

1. Aspects of Vendor Qualification
2. Access Control Parameters
3. Critical Quality Attributes for Testing
4. Vendor Change Control

Quality Agreements

1. FDA Guidance for Quality Agreements
2. Local, Regional and International Vendors

Areas Covered:

1. Introduction to Pharmaceutical Compressed Air
2. Compressed Air - Importance of Quality
3. Pharmaceutical Compressed Air System Design
4. Regulatory Requirements

Contamination Types and their Regulations

1. Solid Particulate Contamination
2. Water Content Contamination
3. Total Oil Content Contamination

Bioburden Contamination

1. Bioburden Measurement
2. Bioburden-Regulations and Specifications
3. Bioburden Removal

Areas Covered:

Regulatory Requirements for Cleanroom Classifications

1. Cleanroom Regulations
2. Air Handling Unit
3. Cleanroom Design Considerations

HVAC Control System

1. Air Flow Patterns and Rates
2. Temperature and Humidity Controls
3. Electrostatic Controls
4. HEPA Filtration

HVAC Monitoring and Validation System

1. Non-Viable Particulate Monitoring Systems
2. Microbial Monitoring Systems
3. Personnel Practices in Cleanroom
4. HVAC System Validation

Areas Covered:

Understanding Human Error: Factors and Causes

1. Background on Human Error Phenomena
2. Types of Error
3. Human Error Cause Categories

Human Error Prevention Program

1. Tools for Preventing Human Error
2. Root Cause Determination Tool
3. Cognitive Load Tool

Areas Covered:

Method Validation and Common Deficiencies

1. Types of Medications
2. Deficiencies Related to Method Validation
3. Drug Development Process
4. Factors Affecting Quality of Medicines

Validation Requirements for Analytical Procedures

1. cGMP and ICH Guidelines
2. Validation Characteristics
3. Stress Testing

Re-validation of Analytical Procedures

1. Life Cycle of Analytical Methods
2. Re-validation: When is it Necessary
3. General Requirements for Verification
4. Relationship of Verification, Validation and Re-validation

Areas Covered:

Conducting Laboratory Audits

1. Importance of Laboratory Audits
2. Procedure for Laboratory Audits
3. Audit Rating, Report and Follow-up

Comprehensive GMP Audit Items

1. Auditing Laboratory Quality Systems
2. Documentation and Procedures
3. Auditing Equipment, Methods and Material

Sample Handling and FDA Inspection Findings

1. Sampling and Data Workflow
2. Record Archiving and Stability Testing
3. Inspection Deviations

Areas Covered:

GLPs vs GMPs

1. What are GLPs and GMPs?
2. Intent of Regulations
3. Basic Elements of GLP

GLPs Guidelines

1. GLPs-Organization and Personnel
2. GLPs-Facilities and Equipment
3. GLPs-Records and Reports

What are GMPs?

1. cGMPs-General Provisions
2. Organization and Personnel
3. Buildings and Facilities
4. Equipment
5. Control of Components

GMPs Guidelines

1. Production and Process Controls
2. Packaging and Labeling Control
3. Laboratory Controls
4. Records and Reports
5. Returned and Salvaged Drug Products

Areas Covered:

BIMO Inspection Program

1. Key Terms and Responsibilities
2. General Purpose of FDA Inspection
3. BIMO Program
4. Inspection Focal Points

FDA Inspection Process

1. Notification of Inspection
2. Inspection Preparation Strategies
3. Do's and Don'ts during Inspection

How to Respond to the FDA

1. Possible Inspection Outcomes
2. Common Deficiencies
3. Best Practices to Respond to FDA

Areas Covered:

Definition and application of HIPAA

The importance of HIPAA within an organization

Specific rules and regulations of HIPAA;

1. HIPAA Enforcement
2. Patient Rights
3. HIPAA Privacy Requirements
4. The Breach Notification Rule
5. Release of Information (ROI)
6. HIPAA Security Rule
7. PHI Safeguarding Tips
8. Business Associate Agreements

An overview of HIPAA violations and complaints

Areas Covered:

The course will help you understand

1. What is money-laundering
2. The requirements of US anti-money laundering regulations
3. Why money laundering is a huge risk for banks and other financial institutions
4. Red flags of money laundering
5. How to identify suspicious behavior associated with money laundering

Areas Covered:

Requirements of US Anti-money Laundering Regulations

1. Bank Secrecy Act (BSA)
2. US PATRIOT Act

The Important Regulatory Reporting Requirements under AML Laws

1. Currency Transaction Report (CTR)
2. International Transportation of Currency or Monetary Instruments Reporting (CMIR)
3. Report of Foreign Bank and Financial Accounts (FBAR)
4. Suspicious Activity Report (SAR)

Best Practices to Prevent Money Laundering

Customer Identification Program (CIP)

Customer Due Diligence (CDD) Program

BSA/AML Risk Assessment

Identification and Reporting of Suspicious Activity

Areas Covered:

Areas Covered:

Areas Covered:

Foreign Corrupt Practices Act (FCPA) Basics

1. History and Background
2. Importance of FCPA Compliance
3. Costs of Non-Compliance

FCPA Provisions:

1. Basic Principles of the FCPA
2. Description of FCPA - Bribery Section
3. FCPA Accounting Provisions
4. Exceptions to the FCPA

Red Flags for FCPA Violations:

1. Red Flags for FCPA Anti-bribery Section
2. Red Flags for Agents
3. Red Flags for FCPA Accounting Violations

Entertainment and Travel Expenses

Areas Covered:

Conflict Mineral Basics

1. Definition of a Conflict Mineral and its Usage
2. SEC's Conflict Mineral Rule and its Requirements
3. Why Compliance is Necessary?

How to Comply with the SEC Conflict Mineral Rule

1. Applicability of Rule
2. Reasonable Country of Origin Inquiry (RCOI)
3. Due Diligence
4. Monitoring Supply Chain
5. Risk Assessment

Reporting Requirements and Third Party Audits

1. Conflict Minerals Report
2. Filling in the Form SD
3. Due Diligence Outcomes
4. Third Party Audits