One of the fundamental concepts of cGMP is that companies that manufacture or test medicines should have systems in place that ensure the safety, purity and efficacy of the marketed drugs. One of the pillars of this philosophy is that companies must be self-healing to maintain a State of Control; in other words, when a problem arises, that problem can be detected and subsequently corrected. The current expectation for US and EU regulators is that the Deviation/CAPA systems that are in place should be robust enough to Detect an event; put temporary measures in place to contain the problem; have a team of experts trained to investigate and determine root cause; then put a solution in place that stands the test of time.
Whether the event occurs with a patient in the market or on the shop floor or in the lab, the progression is always the same: Event Detection → Investigation → Root Cause Analysis → Testing of Root Cause → Development of Solution → Test & Implementation of a Solution → Verification that the Solution is Robust (Effective).With the advent of ICH-Q9, all of the above steps are required to be performed within the context of Risk Analysis and Impact Assessment.
US FDA has historically pegged “inadequate investigation” as one of the top 3 observations year on year. Inadequate Investigations and weak CAPAs are a straight path to receiving an Import Alert, Warning Letter and/or EU Non-compliance Report.
A small investment to ensure the workforce is fully trained in Investigation and CAPA is the best insurance to avoid regulatory action that can have a negative market impact on the company and potentially huge cost for remediation.
In this two day workshop conference you will learn what global regulators expect for Investigation, Root Cause Analysis (RCA), Corrective Action and Preventative Action (CAPA), Risk Analysis and Impact Assessment. During the workshop we will analyze case studies and perform class activities to better understand both theory and some practical approaches to performing comprehensive investigations with robust CAPAs that are scientifically justifiable.
Learning Objectives:
Upon completing this course participants should:
- Understand the history and expectations for global regulators for Investigation and CAPA
- Understand the vocabulary of Investigation and CAPA
- Understand the difference between the CAPA system and a CAPA
- Understand how to reduce bias while improving the approach to Event Investigation (Deviation / OOS / Non-conformance / etc.)
- Understand the difference and roles of both Risk Analysis and Impact Assessment in Investigation and CAPA
- Learn about the tools of investigation and how to apply them
- Learn what GMP transactional mapping is and how to apply it to investigation, risk assessment and RCA.
- Learn the difference between the signals of an event and True Root Cause
- Problem solving methods to help you asses select the best solution for the root cause
- Develop successful CAPA implementation plans
- Learn why the Justification for the CAPA is equally important as the solution itself
- How to prepare and present the Investigation and CAPA program to investigators during an inspection
- The many uses of CAPA beyond just closing deviations (CAPA as an Agent of Change)
Who will Benefit:
This course is designed for people throughout the GMP Operations. As deviations can occur anywhere within the GMP environment it is imperative that all personnel have some understanding of Investigation and the functions of CAPA. In addition, there also need to be some few select SMEs within the organization to guide with process / compliance knowledge as required. While it is the Quality Unit that owns the systems, it is operation personnel who are most familiar with the occurrence of events and have specific process knowledge to determine the potential source of the Root Cause.
In addition, as CAPA is a major Quality Management System, the Quality Unit Management has specific responsibility for making general improvements in their organization’s performance and presenting (reporting) the systems to the QMR, regulatory inspectors and soon to Regulatory Agencies as part of Quality Metrics requirements.
Following personnel will benefit from the course:
- Executive Management and Senior Quality Managers
- Quality Professionals
- Regulatory Professionals
- Compliance Professionals
- Production Managers, Supervisors and Operators
- Manufacturing Engineers
- Warehouse Managers, Supervisors and Personnel
- Calibration, Preventive Maintenance and Production Engineers
- Process and Department Owners
- Quality Engineers
- Quality Auditors
- Deviation & CAPA System Personnel
- Designated Investigators and Process Improvement Personnel
- Registration Process: 8:30 AM – 9:00 AM
- Introduction Investigation and CAPA
- What is an Investigation?
- What is a Correction?
- What is a Corrective Action vs a Preventive Action?
- Why are Investigation and CAPA important?
- Regulatory requirements and the inspector’s expectations
- The meaning of adulteration
- History of the Deviation & CAPA System
- Impact and cost of Poor Investigation and CAPA
- Current Regulatory Thinking and 483s Data
- Impact of Global Harmonization (ICH)
- Future expectations
- The Event Reporting & CAPA System
- Why is discussing CAPA so hard?
- Vocabulary of CAPA
- Sequence of Investigation and CAPA
- Commonalities for CAPA
- Ideal CAPA System
- Event Characterization
- What is it
- Bias in investigation and how to neutralize it
- Signals and how to interpret them
- Event Characterization Exercise
- Investigation
- Data Mining
- Tools of Investigation
- GMP Transactional Mapping
- Root Cause Analysis (RCA)
- Analyzing Data
- Signals and RCA
- Null Hypothesis
- DOE for turning on / off the problem
- RCA Justification and Reporting
- Risk Analysis and Impact Assessment
- ICH-Q9 and why Risk is a requirement
- Tools of Risk
- Role of Impact Assessment
- GMP Awareness Exercise
- CAPA Planning & Execution
- Root Cause and developing Corrective Actions or Preventive Actions
- DOE’s and robust solutions
- What will be our metrics for success? (Efficacy planning)
- Case Study Exercises from Typical Real Life Problems
- The Case of the Shop Floor Data Integrity Conspiracy!
- Customer Compliant: Patient found a small Purple Tablet in a Bottle of large White Tablets
- Media Fill Failure Investigation (Successful use of Transactional Mapping)
- Questions
Warford Reaney
Consultant and Mentor
Mr. Reaney has over twenty-five years’ experience in building, developing and managing teams to solve complex technical, regulatory, compliance and business challenges. His broad knowledge includes serving in Executive and Quality Management for multi-national corporations, biopharma start-ups and established pharmaceutical enterprises. Years of direct hands on involvement provide specific abilities to assist life science companies who serve or are entering the US/EU markets to achieve their technical, quality, product and financial goals within a context of good science and FDA / EU compliance. His frequent interaction with the USFDA enables him to assist manufacturers to meet the most current regulatory expectations.
Mr. Reaney has spent many years in India immersed in the diverse cultures and unique ways of business: As a teenager, he lived for several years with his parents in Hyderabad when his father worked for UNDP introducing technology for the nascent Indian Sponge Iron industry; after his university studies, he returned to India on a Fulbright Scholarship for two years; then in 2007, he and his wife moved to Indian and have been working with and mentoring Indian, US & EU companies who have operations in India and abroad for GMP manufacturing of API, OSD and Parenteral Formulations and for Biotech manufacturing.
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Local Attractions of Kuala Lumpur, Malaysia
PETRONAS Twin Towers
One of the most iconic sights in the world, the PETRONAS Twin Towers feature postmodern architecture and style and also feature Islamic designs. Visitors flock here for the walk over the sky bridge that joins the two towers together and you can admire the breathtaking views that stretch across the city of Kuala Lumpur. A visit to Kuala Lumpur just is not complete unless you have visited these doppelganger structures.
Chinatown
The colourful Chinatown is a well-known bargain hunter’s paradise that seemingly never sleeps. Deeply immersed in Oriental culture, heritage and history, it is undoubtedly one of the most popular tourist spots in Malaysia. Representing Malaysia’s multihued multicultural background perfectly, you can find all sorts of stuff, from Chinese herbs to imitation goods in this area.
Batu Caves
Batu Caves is a limestone hill that has a series of caves and cave temples in Malaysia. It is best known as the focal point of the annual Hindu festival of Thaipusam. The celebration attracts thousands of visitors who come to see the colourful spectacle of devotees who pay homage by carrying ornately-decorated ‘kavadis’
Sultan Abdul Samad Building
Sultan Abdul Samad Building is the home to the offices of the Ministry of Information, Communications and Culture of Malaysia. Built in 1897 and designed by AC Norman, it is set to the east of Merdeka Square (Dataran Merdeka) and is frequently the backdrop for Malaysia’s annual Independence Day parades.
Sunway Lagoon Theme Park
Here you’ll find five different theme parks in one amazing destination, with more than 80 rides and attractions to choose from. Experience the world’s largest man-made sandy surf beach, world’s longest pedestrian suspension bridge, Asia’s highest slingshot ride, Malaysia’s first interactive zoo and one of Asia’s longest flying fox trails.
Local Attractions of Taipei, Taiwan
Shilin Night Market
Taiwan is famous for its night markets. Shilin is the most famous night market in Taipei, and not without good reason. You can get the best deals on the latest fashion trends in Asia, or try a ton of foods you’ve never seen before.
The National Palace Museum
This stunning museum is filled with the world’s largest collection of Chinese art. It houses roughly 700,000 ancient artifacts from China, as well as internationally renowned artwork. You’ll find, for example, a beautifully crafted cabbage made of jadeite, complete with insects crawling over it.
Chiang Kai-Shek Memorial
This famous monument was built to celebrate the life and success of Taiwan’s former president Chiang Kai-Shek. It is notable for its unique architecture, which incorporates symbolism in numbers and shapes.
Taipei 101 Light Shows
The light shows from the top of the famous skyscraper Taipei 101 are one of the top attractions to see in Taipei. Use this landmark skyscraper to get your bearings when you arrive in the city - its blend of contemporary architecture and allusions to traditional bamboo structures stands head and shoulders above the skyline.
Beitou Hot Springs
The Hot Springs Museum, which is actually in an old Japanese bathhouse, is a unique place to visit in Taipei. Not only will you learn more about how the waters and steam were harnessed for the benefit of the people, you’ll also be able to view the springs with a walking tour.
