Three interactive modules that tackle the requirements and the discipline needed to consistently manually document and electronically record the manufacturing & testing of APIs, Drug Formulations, Biosimilars and Vaccines:
Manual Entries: "If you didn’t write it down per ALCOA...
Electronic Transactions: "If it wasn’t validated per Part 11 with intact audit trails...
it didn't happen"
- FDA / EMA: Expectations for Data Integrity Ethics, Law and Transparency
- Data Integrity Reality: Detect; Panic; Investigate; Report and Repair
- Documentation Best Practices
- Electronic Data Governance in the GMP Environment
Learning Objectives:
- Regulatory Expectations and Laws regarding Data Integrity and Electronic Data Governance
- How to handle Data Integrity challenges of detection, investigation, regulatory response and CAPA
- Case Studies that describe real life examples of how companies have handled Data Integrity Issues and how the regulators reacted
- Best Practices for creating GMP appropriate Documentation
- How to encourage GMP Documentation discipline on the shop floor, warehouse and labs
- How the interactive role of the quality systems and plant management can bring about a culture of good GMP documentation
- Electronic Data Governance: Regulatory expectations; what documents / policies / procedures should be in place; how to define the GMP boundaries around automated systems; role of Quality Assurance with automated systems; what to do and how to investigate if there are electronic data integrity problems.
Who will Benefit:
- QA Personnel
- QA-IT Personnel
- IPQA Personnel
- QC Personnel
- Manufacturing Personnel
- Engineering Personnel
- Warehouse / Material Management Personnel
- GMP Management Personnel
- R&D Personnel involved with Tech Transfer
- GMP API Personnel
- Non-GMP Intermediates Personnel
- CRO / CRAMS Personnel
- HR Personnel
- Introduction to 2-day event
- Module 1: FDA: Expectations for Ethics, Law and Transparency
- History and the Role of Ethics and the Law in US Pharma
- American vs European approach to GMPs & the impact of ICH
- Regulatory requirements and the inspector’s expectations
- Cultural Do’s and Don’ts (how normal behavior can be severely misunderstood)
- What you should be ready for when the FDA knocks at the door for an Unannounced Inspection!
- Future inspection expectation trends and the next big Warning Letter problem with personnel
- Questions
- GMP Awareness Exercise
- Module 2: Data Integrity Reality: Detect; Panic; Investigate; Report and Repair
- Brief history and the Laws of Data Integrity
- What is Human Error? What is an Ethical Error?
- Case Study 1: Why Data Integrity in South Asia is complicated & the role of many cultures
- Brass Tacks: Who does it and where to find DI Issues
- Case Study 2: When personal ethics overwhelm compliance
- Simple Plan of Action if you find DI Issues
- Case Study 3: When Data Integrity is actually Fraudulent
- How to report and communicate DI issues with regulators
- How to Fix DI issues!
- Questions
- Recap of Day 1
- Module 3: Documentation Best Practices
- What are Regulatory Expectations for Documentation?
- Basics of Good Documentation Practices
- Defining the Boundaries for Required GMP Documentation
- Detecting GDP Errors and Evaluating for Data Integrity Issues
- Defining & Training for Best Practices for GMP Documentation
- Encouraging and Enforcing Discipline in Documentation
- Questions
- Module 4: Electronic Data Governance in GMP Operations
- Part 11 / Annex 11 and what regulators expect in an electronic data environment
- Controls for Electronic Data and Defining the Boundaries for Data Governance
- Typical Automation Systems used in the Pharmaceutical Operations
- What are the considerations for culture when migrating from Manual Entries to Electronic Transactions
- State of Control: The role of Computer System Validation and the interaction between workers and automated systems to maintain GMP compliance
- Considerations for Electronic Data Integrity detection, investigation and CAPA
- Questions
Warford Reaney
Consultant and Mentor
Mr. Reaney has over thirty years' experience in building, developing and managing teams to solve complex technical, compliance and business challenges. His has served in Executive and Quality Management from small technical start-ups to multi-national enterprises. Years of direct hands on involvement provide specific abilities to assist biopharma companies who serve or are entering the US/EU markets to achieve their technical, quality, product and financial goals. His frequent interaction with the USFDA enables him to assist manufacturers to meet the most current regulatory expectations.
Mr. Reaney is successful at mentoring and assisting companies to implement a program to continuously detect and over time develop a culture of accountability that eradicates data integrity problems and puts in place a sustaining and measurable way to tie Continuous Improvement with Personal Motivation.
He is immediately able to engage local teams to improve their knowledge and application for effective investigation & CAPA efforts. An acknowledged expert in CAPA system & team development for rapid compliance and internal process cultural change and long-term efficacy documentation.
In addition he has many helpful tools to assist quality and production personnel to better understand their operations through GMP transactional process mapping, compliance focused FMEA, decision tree development and proven methods for investigation & Root Cause Analysis.
Warning Letter & 3rd Party Release: Mr. Reaney has worked as Team Lead for both Warning Letter Remediation and 3rd Party Product Release projects. His approach includes evaluation and documentation of the current State of Control for both GMP operations and product.
Mr. Reaney has strong competence in FDA GMP Inspection Gap Assessment that specifically evaluates the ability of a company to successfully withstand an FDA Inspection. His expertise comes from having trained on-the-job with a former FDA inspector who was for four years the head of PAI inspections for the FDA Philadelphia district office and is an adjunct professor at Temple University in Quality Science. He is her representative in India for GMP Audits and Gap Assessments.
He has worked with clients across the globe to prepare them for FDA Inspection with great success of passing inspections with only minor observations. For clients in trouble, he has assisted with telephone & face to face meetings with FDA to effectively communicate regulatory and/or compliance issues, proposed solutions and follow up evidence of remediation. He has led efforts for 483 and Warning Letter response & remediation and for 3rd party release of products to the US & EU markets.Register Now
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