Two interactive modules that tackle the both the requirement and the discipline needed to consistently document the manufacturing and testing of APIs, Formulations and Vaccines:


  • FDA: Expectations for Data Integrity Ethics, Law and Transparency
  • Data Integrity Reality: Find; Panic; Investigate; Report and Repair
  • Culture, Ethics, Human Error and GMP Compliance Challenges
  • Documentation Best Practices
Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives::

  • Regulatory Expectations and Laws regarding Data Integrity
  • 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
  • Understanding the process and cultural Root Causes for Human Errors and how to reduce them
  • 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

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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(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 02(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
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Warford Reaney

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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Seminar One Registration (USD)

April 18-19, 2018, Dhaka, Bangladesh
(Registrations till March 25, 2018 - $499)
(Registrations after March 25, 2018 - $799)

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April 18-19, 2018, Dhaka, Bangladesh
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  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location

    Six Seasons Hotel,
    House #19, Road-96, Gulshan-2,
    Dhaka 1212, Bangladesh
    Tel: +88-029-840-789

    April 18-19, 2018

    How to Reach

    General Driving Directions:

    Driving Directions from Hazrat Shahjalal International Airport: 7.8 Km
    • Continue to Dhaka - Mymensingh Hwy
    • Drive along Pragati Ave
    • Continue to Bridge/Madani Ave
    • At the roundabout, continue straight onto Bridge/Madani Ave
    • Drive to Rd No 96 and turn left onto Rd No 96, hotel will be on the left.

    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. ComplianceOnline is not responsible for any inaccuracies in the same.

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    For more details and other sponsorship options at this event, please contact Event Manager: or call: +1-650-238-9656

    Media Partner:

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    Local Attractions of Dhaka, Bangladesh

    Ahsan Manzil

    Ahsan Manzil

    Ahsan Manzil is one of the most significant architectural monuments of Bangladesh. It was the official residential palace and seat of the Dhaka Nawab family. This magnificent building is situated at Kumartoli along the banks of the Buriganga River in Dhaka. The construction of this palace was started in 1859 and was completed in 1872. It was constructed in the Indo-Saracenic Revival architecture. It has been designated as a national museum.

    Bangladesh National Museum

    Bangladesh National Museum

    The Bangladesh National Museum originally established on 20 March 1913, albeit under another name (the Dhaka Museum), and formally inaugurated on 7 August 1913, was accorded the status of the national museum of Bangladesh on 17 November 1983. It is located at Shahbag, Dhaka. The museum is well organized and displays have been housed chronologically in several departments like department of ethnography and decorative art, department of history and classical art, department of natural history, and department of contemporary and world civilization. The museum also has a rich conservation laboratory.

    Dhakeshwari Temple

    Dhakeshwari Temple

    Dhakeshwari National Temple is a Hindu temple in Dhaka, Bangladesh. It is state-owned, giving it the distinction of being Bangladesh's 'National Temple'. The name "Dhakeshwari" means "Goddess of Dhaka". Since the destruction of Ramna Kali Mandir in 1971 by the Pakistan Army during the Bangladesh Liberation War, the Dhakeshwari Temple has assumed status as the most important Hindu place of worship in Bangladesh. The Dhakeshwari temple was built in the 12th century by Ballal Sen, a king of the Sena dynasty, and many say the city was named after this temple.

    Liberation War Museum

    Liberation War Museum

    The Liberation War Museum is a museum in Segunbagicha, Dhaka, the capital of Bangladesh that commemorates the Bangladesh Liberation War, which led to the independence of Bangladesh from Pakistan.
    The museum opened on 22 March 1996, and has more than 9,000,000,000 artifacts and exhibits on display in the museum or stored in its archives. It is currently being rebuilt. The galleries on the ground floor begin with covering the early history of Bangladesh and the Indian independence movement against British Raj in Bengal. A major section records the events of the Language Movement for the recognition of the Bengali language in Pakistan, which is regarded as the beginning of the movement for Bangladesh's independence.

    Star Mosque

    Star Mosque

    Star Mosque is located in Armanitola area, Dhaka, Bangladesh. The mosque has ornate designs and is decorated with motifs of blue stars. It was built in the first half of the 19th century by Mirza Golam Pir (Mirza Ahmed Jan). The mosque was first built by Mirza Ghulam Pir, as a three domed oblong edifice. But an over enthusiastic and zealous merchant named Ali Jan Bepari completely remodeled and reconstructed it with extremely delicate and richly colored tiles of variegated patterns.

    Dhaka Zoo

    Dhaka Zoo

    Dhaka Zoo is a located in the Mirpur section of Dhaka. The zoo contains many native and non-native animals and wild life, and hosts about three million visitors each year. Established in 1974, the 186-acre (75 ha) Dhaka Zoo is the largest zoo in Bangladesh, and is operated by the Ministry of Fisheries and Livestock. The zoo attracts around 10,000 visitors every day with the number increasing during the weekends and holidays. The yearly budget of Dhaka Zoo is Tk 37.5 million, out of which Tk 25 million is spent on feeding the animals.

    Ramna Park

    Ramna Park

    Ramna Park is a large park and recreation area situated at the heart of Dhaka, the capital city of Bangladesh. This park is one of the most beautiful areas in Dhaka with lots of trees and a lake near its center. The history of Ramna starts about 1610 CE during Mughal rule, when the city of Dhaka was founded by Subehdar Islam Khan under Emperor Jahangir. At that time two beautiful residential areas were developed in the northern suburb of Dhaka city. New residential houses, gardens, mosques, tombs and temples were built in this area during that period. After the fall of the Mughal rule, Ramna gradually lost much of its glory. Ramna was then a barren area with bushes, abandoned or dilapidated buildings, tombs and old temples.

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