Канал: Compliance Trainings

Pharmaceutical Validation – Latest Global Regulations and Trends to Stay Compliant

Pharmaceutical Validation – Latest Global Regulations and Trends to Stay Compliant

Pharmaceutical Validation Workshop

Pharmaceutical Validation Workshop

Seminar on Computer System Validation (CSV), Data Integrity and 21 CFR Part 11 Compliance

Seminar on Computer System Validation (CSV), Data Integrity and 21 CFR Part 11 Compliance

Transfer of Analytical Methods and Procedures according to USP 1224

Transfer of Analytical Methods and Procedures according to USP 1224

Using Metrics to Monitor and Improve Your Quality System 2015

Using Metrics to Monitor and Improve Your Quality System 2015

Validation and Use of Excel® Spreadsheets in Regulated Environments

Validation and Use of Excel® Spreadsheets in Regulated Environments

Validation of Analytical Methods according to the New FDA Guidance

Validation of Analytical Methods according to the New FDA Guidance

Robust CAPA

Robust CAPA

Quality System from Medical Devices to Manufacturing of Combination Products

Quality System from Medical Devices to Manufacturing of Combination Products

Pediatric Drug Development – Relevant FDA Laws and Changing Approach

Pediatric Drug Development – Relevant FDA Laws and Changing Approach

Medical Devices Designing withe Cleanliness in Mind

Medical Devices Designing withe Cleanliness in Mind

Medical Device Changes and the 510k

Medical Device Changes and the 510k

Learning from Recent FDA Warning Letters related to Part 11 and Computer Validation

Learning from Recent FDA Warning Letters related to Part 11 and Computer Validation

Key Regulatory Documents Design History File DHF, Device Master Record DMR, Device History Record D

Key Regulatory Documents Design History File DHF, Device Master Record DMR, Device History Record D

Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs

Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs

ISO 13485 2015 Proposed Changes and Medical Devices Quality Management Systems

ISO 13485 2015 Proposed Changes and Medical Devices Quality Management Systems

Implementing an Internal Audit Program of QMA, Persisting to ISO 13485 and 21 CFR Part 820

Implementing an Internal Audit Program of QMA, Persisting to ISO 13485 and 21 CFR Part 820

Hazard Analysis and Product Risk Management under ISO 14971 and ICH Q9

Hazard Analysis and Product Risk Management under ISO 14971 and ICH Q9

Good Laboratory Practice Regulations Introduction and Strategies for Implementation

Good Laboratory Practice Regulations Introduction and Strategies for Implementation

Good Documentation For Clinical Trials

Good Documentation For Clinical Trials

FDAs New Enforcement of 21 CFR Part 11

FDAs New Enforcement of 21 CFR Part 11

Root Cause Analysis

Root Cause Analysis

Ensuring Data Integrity for FDA EU Compliance

Ensuring Data Integrity for FDA EU Compliance

Developing a Compliance Risk Management CRM Model for Your Company

Developing a Compliance Risk Management CRM Model for Your Company

Corrective and Preventive Action CAPA utilizing the Principles of Lean Documents and Lean

Corrective and Preventive Action CAPA utilizing the Principles of Lean Documents and Lean

Computer System Validation

Computer System Validation

Best Practices for Communicating and Interacting with FDA Reviewers

Best Practices for Communicating and Interacting with FDA Reviewers

Affordable Care Act Updates – 2015 What Employers Need to do to Prepare

Affordable Care Act Updates – 2015 What Employers Need to do to Prepare

Advanced Course on Lean Documents, Lean Configuration and Document Control for Medical Devices

Advanced Course on Lean Documents, Lean Configuration and Document Control for Medical Devices

21 CFR Part 820 Quality System Regulation Applying Principles of Lean Documents and Lean

21 CFR Part 820 Quality System Regulation Applying Principles of Lean Documents and Lean

FDA Quality Metrics and Risk Based Inspections

FDA Quality Metrics and Risk Based Inspections

Pharmaceutical QMS - Applying The Priniciple

Pharmaceutical QMS - Applying The Priniciple

Comparison Of The FDA's Three Major Regulations

Comparison Of The FDA's Three Major Regulations

GMP Data Integrity Best Practices and Regulatory Expectations

GMP Data Integrity Best Practices and Regulatory Expectations

Good Documentation Practices

Good Documentation Practices

Effective Training Practices for FDA Compliance

Effective Training Practices for FDA Compliance

Comparing GLP with GMP

Comparing GLP with GMP

Part 11 Compliance and the Role of Standard Operating Procedures

Part 11 Compliance and the Role of Standard Operating Procedures

Verification vs Validation

Verification vs Validation

Internal Auditing What you need to know

Internal Auditing What you need to know