Three modules for success:
- FDA: Expectations for Ethics, Law and Transparency
- Data Integrity Reality: Detect; Panic; Investigate; Report and Fix
- 4 Dominos: Procedures; Investigation; OOS & CAPA
FDA unannounced inspections today are only as far away as a terrifying call from the main gate. Gone are the days a few weeks of concentrated effort to clean up documents before the inspectors arrive would suffice.
OMG! The stakes could not be higher… think of the BLACK EYE that a Warning Letter brings… it CRASHES your stock price… send your customers RUNNING to COMPETITORS… ceases all forward movement on ANDA filings… COST tens of CRORE to fix and takes TWO or more YEARS to come clean with the FDA.
In GMP Business it is the least of things that can have the greatest impact. Small errors, undisciplined behavior, “best of intention” thinking has killed companies.
FDA’s perspective: Pure Data = Pure Drug. Data without Integrity = ADULTERATION
Course: Practical no-nonsense two-day course will prepare you, your management and departmental staff to understand how American investigators think and how to focus on the big ticket items that end in Warning Letter.
Simple Logic to take the course:
- Vehicle insurance:
- Cost: ~ 2 % value of vehicle per year
- Accident Occurrence: Unlikely
- Inspection Readiness Training:
- Cost: ~ 0.05% value of annual revenues to send (5) people to this (2) day course
- Inspection Occurrence: Certainty
Upon completing this course participants should learn:
- Module 1: USFDA/EU: Expectations for Ethics, Law and Transparency
- Understand the history and expectations for compliance from US & EU regulators in inspection
- Understand the vocabulary of inspection and how Inspectors use odd questions to verify the truth of statements
- Module 2: Data Integrity Reality: Detect; Panic; Investigate; Report and Fix
- The vocabulary and the laws regarding Data Integrity
- Where DI occurs and how to detect it
- Why DI errors occur
- The Role and Importance of Management lower the risk of DI errors
- Difference between Human Error, Ethical Mistakes and Fraudulent Behavior
- How language can influence compliant / non-compliant behavior
- Simple Steps to Take if a DI problem is found
- How to develop a CAPA to resolve past and prevent future DI errors
- How to best report DI errors to the regulators
- How to best handle and present known DI errors for an inspection
- How to best handle and manage communication if an unknown DI error arises during an inspection
- Module 3: Four (483) Dominos: Procedures; Investigation; OOS & CAPA
- Main compliance problems with procedures
- Main compliance issues with training on procedures
- Understand how to reduce bias while improving the approach to Investigation
- Learn about the tools of investigation and where to apply them
- Understand the difference and roles of both Risk Analysis and Impact Assessment in Investigation
- OOS as a system and an event
- Main compliance problems with OOS and OOS investigation
- Understand the vocabulary & differences between the “CAPA System” and “a CAPA”
- Learn what GMP transactional mapping is and how to apply it to investigation
- Learn the difference between the signals of an event and True Root Cause
- Learn the importance of Justification in Investigation, OOS and CAPA
- How to prepare and present the Investigation and CAPA program to investigators during an inspection
- “Inadequate Procedures” Risk: Examples of what is missing from SOPs and documents; logical hierarchy of documents from Level 1 Policies to shop floor Work Instructions; typical Lab Procedure gaps for Specifications, Test Methods, Validations, Record Keeping; how to stay out of inspection trouble with Procedures.
- “Inadequate Investigation” Risk: What it is; Level 1 vs Level 2; Event reporting and approach to Investigation; Problem Statement Development; quick Risk measure & escalation; Level 1 justification and Corrective Actions.
- OOS Risk (“Inadequate Lab Controls”): Significance of OOS as a Quality System; why inspectors focus on OOS; recent WL observations for Invalidated OOS and how to come out of trouble; investigation requirements for OOS; RCA and OOS; human error and OOS.
- CAPA Risk (the “hidden” Quality System): What is the CAPA System; Regulatory expectations for CAPA; escalation to Level 2 investigation (non-Lab); uses and reporting of CAPAs; proper use of Risk Analysis and Impact Assessment; Regulatory Requirements for and Effective Data Mining; Root Cause Analysis; Transactional Mapping; solution development, Design of Experiment (DOE) and Null Hypothesis; Selecting effective milestones for monitoring efficacy; how to get out and stay out of trouble with CAPA.
Years of Warning Letters, Import Alerts, Rescinded GMP Certification, Drug Withdrawals and Unannounced Inspections have dropped many companies into huge financial losses, market retreat and sometimes forced liquidation. Business strategy, product pipeline and hard work can be wiped out in a few days of unexpected findings, cross-cultural misunderstanding and misaligned expectations. Key to inspection success is having a complete understanding of the expectations of regulators.
This module brings years of research into simple terms to explain the thinking, bias and rationale of the DIFFERENT approaches US and EU inspectors have to inspection; provide a clear path through the laws that effect sourcing, manufacturing, testing and marketing drugs; and specific expectations that US and EU regulators have for transparency at all levels of data generation, recording and communication. Included in this module are some unexpected “do’s” and “don’ts” that are based on cultural norms in the US and EU.
Data Integrity Warning Letters have had a huge impact on India Pharmaceutical and CRO companies for the last couple of years. The problem is found in different ways in almost every company and has been the focus of US and EU regulators for several years. The response to DI problems by regulators is swift and severe.
This module brings clear understanding of not only what Data Integrity is, but where to find it, how to detect it, what to immediately do when it is discovered, how to communicate with regulators and through CAPA how to fix it. Included is are (3) specific case studies that demonstrate how best of intentions, human error and ethical behavior can lead to severe data integrity non-compliance.
More than half of all FDA Observations are captured in the (4) areas of: Inadequate or missing procedures; poor or inadequate investigation; and poor or lack of Laboratory Controls.
These topics will be covered in-depth from the point of view of the US and EU inspector such that you will be able to determine on your own if you have any gaps in your existing systems. In addition, this course will also provide the correct approach and tools to use with regulators in the event any of these dominos should fall at your plant.
The following are included in this module:
Who will Benefit:
This course is designed for people throughout the GMP Operations with special emphasis for Middle Management, Decision Makers who affect Quality and both the QC / QA Units.
- Executive Management and Senior Quality Managers
- Quality Professionals
- Regulatory Professionals
- Compliance Professionals
- Production Managers, Supervisors and Senior Operators
- Manufacturing Engineers
- Warehouse Managers, Supervisors and Senior Personnel
- Calibration, Preventive Maintenance and Production Engineers
- Process and Department Owners
- Quality Engineers
- Quality Auditors
- Deviation & CAPA System Personnel
- Compliance Personnel
- Designated Investigators and Process Improvement Personnel