Data Integrity, Good Documentation Practices and Electronic Data Governance: 2-Day In-Person Seminar

By: Warford Reaney, Consultant and Mentor
Location :- Hilton Singapore | Thursday, July 5, 2018 | Friday, July 6, 2018

Course Description:


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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:

DATA INTEGRITY MEANS

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
  • IPQA Personnel
  • QC Personnel
  • Manufacturing Personnel
  • Warehouse / Material Management Personnel
  • GMP Management Personnel
  • R&D Personnel involved with Tech Transfer
  • GMP API Personnel
  • Non-GMP Intermediates Personnel
  • CRAMS Personnel
  • HR Personnel

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 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
Day Two (8:30 AM – 4:30 PM)
  • Recap of Day 1
  • Module 3: Culture, Ethics, Human Error and GMP Compliance Challenges
    • What are Human Errors?
    • What are the sources of Human Errors?
    • Why the FDA says that “Human Error” is not an acceptable Root Cause
    • Root Cause Investigation for Human Errors
    • Understanding how Culture influences Human Errors
    • GMP Transactional Mapping to isolate and fix Human Error problems
    • Case Study 4: Human Error Remediation
    • Questions
  • Module 4: 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

Meet Your Instructor

Warford Reaney
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.

Venue

Location :
Hilton Singapore
581 Orchard Road,
Singapore 238883, Singapore
Tel: +65-6737-2233

July 5-6, 2018


How to Reach

General Driving Directions:

From Changi International Airport – 13 miles
  • Taxis are readily available to take you from Changi International Airport to the Hilton Singapore hotel.
  • The journey normally takes around 20 minutes from the airport to the hotel forecourt.

Other Transportation:

Bus Station
  • Many buses to the city center from Changi International Airport stop on Orchard Road, where the Hilton Singapore hotel is located. The journey normally takes around an hour.
Train Station
  • The train journey from the airport to Orchard MRT Station, the underground station nearest to Hilton Singapore hotel, normally takes around 40 minutes.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
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July 5-6, 2018, Singapore
(Registrations till June 18, 2018 - $1299)
(Registrations after June 18, 2018 - $1699)

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Local Attractions:

Singapore Zoo
Since 1973, Singapore Zoo has been known for having among the most beautiful wildlife park settings in the world, where animals roam freely in open and naturalistic habitats. The Singapore Zoo spans 28 hectares within Singapore's heavily forested central catchment area. The zoo, which attracts about 1.6 million visitors per year, boasts 315 animal species, some of 16% of which are considered threatened species.

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Universal Studios Singapore
Universal Studios Singapore is the first and only theme park in Southeast Asia. Go beyond the screen and Ride The Movies™ at Universal Studios Singapore. Only here can you experience cutting-edge rides, shows, and attractions based on your favorite blockbuster films and television series, including TRANSFORMERS The Ride: The Ultimate 3D Battle, Shrek 4-D Adventure, Madagascar: A Crate Adventure, Jurassic Park Rapids Adventure, and more!


Singapore Flyer
The Singapore Flyer is a giant Ferris wheel in Singapore that was constructed between 2005 and 2008. Described by its operators as an observation wheel, it reaches 42 storeys high, with a total height of 165 m (541 ft), making it the world's tallest Ferris wheel, 5 m (16 ft) taller than the Star of Nanchang and 30 m (98 ft) taller than the London Eye.
Underwater World, Singapore
Underwater World, Singapore is Asia's largest tropical oceanarium and one of Singapore's most popular tourist attractions. Opened in 1991, it has more than 2,500 marine animals of 250 species from different regions of the world. It is also involved in several environmental and educational projects, such as the Living in the Ocean Programme, Ocean Ambassador Programme and the Coral Club.

Boat Quay
Boat Quay is a zone offering an eclectic mix of high end restaurants and alfresco dining and lively bars and pubs. Boat Quay is arguably the favorite place to “chill out” for most professionals and expatriates. Lot of options available for drinks, dining from across the world. Most popular are the dining bars along the river. After a nice dinner one can head to one of the many pubs and discs around.


Sentosa Island
Sentosa is a popular island resort in Singapore, visited by some five million people a year. Attractions include a 2 km (1.2 mi) long sheltered beach, Fort Siloso, two golf courses, two five-star hotels, and the Resorts World Sentosa, featuring the theme park Universal Studios Singapore.