How to use Quality Systems and Processes - Training for Pharma Quality Managers

Poor systems knowledge is among the most prominent reasons why many pharmaceutical quality managers fail to make an impact in defining them into their processes. Despite having all the resources, they are unable to maximize their potential - often resulting in FDA 483s and warning letters.

So, it is essential for quality managers to constantly learn, understand the requirements for systems and processes, and stay updated with technological advancements.

Order ComplianceOnline’s comprehensive training modules showcasing how to use key Quality management system and other processes compliance elements to enhance your knowledge as a quality manager to do it right everytime. The content is created and presented by elite experts. You will learn:

• How to define quality and data integrity into processes and systems.
• The risk-based approaches be implemented under CAPA.
• Process validation principles
• The connection between GxP/GMP with document control and IT systems
• The most common software V&V failings and their fixes
• Equipment Qualification
• Tools for data security

Check out what's included in the training package

• Implementing a Robust Data Integrity Program
• Risk-Based CAPA Systems
• Process Validation Principles and Protocols
• GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems
• Equipment Qualification Basics
• Software Verification and Validation Planning to Meet CGMP Requirements
• Ensuring Integrity and Security of Laboratory Data
• Implementing a Robust Data Integrity Program
• This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems. It will cover the common problems from FDA 483 observations and warning letters and teach you how to avoid them.

Areas Covered in the Webinar:

• Regulatory Guidance Review
• Review all Elements Important to Maintaining Data Integrity
• Key Data Integrity Topics
• What are GMP-relevant Data?
• Why Is An Audit Trail Review Important?
• Can Spreadsheets meet Data Integrity requirements?
• Common problems from FDA 483 observations and warning letters and how to avoid them
• Risk-Based CAPA Systems
• Since the US FDA and the EU have repeatedly stated that the majority of quality and regulatory activities are or should be “risk based”. Learn how this can be implemented under CAPA.

Areas Covered in the Webinar:

• FDA's and EU's Emphasis
• QSIT for a strategic, systems analysis of CAPA and high risk concerns
• How to use your Risk Management Tools (per Q9 and ISO 14971)
• CAPA - a crucial series of risk-based lifecycle deliverables
• Corrections and Risk
• Corrective Action and Risk
• Preventive Action and Risk
• Closing the Loop
• Management Review - tying it all together; taking it to the next level
• Process Validation Principles and Protocols
• This Validation training will set forth the regulatory requirements for process validation, and will also include definitions and application of applicable terminology, and hints and recommendations for the more common types of process validation.

Areas Covered in the Webinar:

What is Validation?

When should it be used?

Validation vs. Verification: Which One?

• Different types of validation: Advance, retrospective, and concurrent
• Protocol preparation.
• Different types of validation.
• IQ, OQ, and PQ.
• Case studies and examples.
• GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems
• Attend this webinar to learn the connection between GxP/GMP with document control and IT systems. Attendees will learn how to manage control documents to pass quality audit and information technology systems in compliance with GxP/GMP requirements.

Areas Covered in the Webinar:

• Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product.
• Auditors pay particular attention to documentation to make sure that it complies with GMP and GDP. Therefore, in order for an organization to meet GxP/GMP requirements, it must have a document control system in place.
• Learn how to manage and control documents in compliance with GxP/GMP requirements and be able to pass quality audit. Lean how to manage IT systems in compliance with GxP/GMP requirements.
• Equipment Qualification Basics
• This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. You will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP).

Areas Covered in the Webinar:

Regulatory Requirements and Expectations for Equipment Qualification

• Europe
• FDA
• Validation policy
• Presumption for qualification/validation

General Aspects of Qualification

• Qualification phases, DQ, IQ, OQ, PQ
• Qualification of existing systems and equipment
• Requalification/validation

Performance Qualification

• SOPs
• Writing a qualification protocol, content
• Executing a qualification
• Tests and data
• Documents
• Writing a qualification final report
• Questions
• Performance of a Process Validation
• SOPs
• Writing a process validation protocol
• Guidelines on Validating Analytical Methods
• Content and execution
• Writing the validation plan
• Methodology and performance
• Report writing for method validation
• Presumption for validation
• Support of Equipment Qualification and Process Validation
• External Equipment Qualification and process Validation
• Review of FDA Warning Letters
• Case Study Exercise from Current FDA Warning Letters
• Theoretical Case Exercises
• Questions
• Software Verification and Validation Planning to Meet CGMP Requirements
• This Software Verification and Validation training will help you understand and recognize the most common software V&V failings and their fixes. You will learn how to develop and use a repeatable software V&V template for all software validation projects.

Areas Covered in the Webinar:

• Recent industry failures.
• Tougher FDA Expectations/Requirements.
• Roles of Verification and Validation.
• An FDA 'Model'.
• A Typical Software V&V Protocol/Test Report.
• A Brief Overview of 21 CFR Part 11.
• Legacy, Hybrid, New and ER/ES Systems.
• Expected Regulatory Deliverables.
• Complementary Guidelines, e.g., GAMP.
• Ensuring Integrity and Security of Laboratory Data
• This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.

Areas Covered in the Webinar:

• Eight key FDA/EU requirements for integrity and security of laboratory data
• How FDA inspectors check integrity and security of data
• Most frequent security and integrity issues: going through recent 483's, EIRs and warning letters?
• The importance of limited access to 'individual users' rather than to groups
• FDA compliant definition, acquisition, maintenance and archiving of raw data
• Critical integrity and security issues during the entire life of laboratory data: from data acquisition through evaluation to archiving
• Examples how to ensure and document data integrity
• Documenting changes of laboratory data: paper, hybrid systems, electronic
• The importance of electronic audit trail to document data integrity
• Review of electronic audit trail: who, what, when and how
• Ensuring timely availability through validated back-up and archiving
• Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions