Workshop Details

Dates

September 18, 2024

Time

2:00 pm – 3:00 pm

Cost

CAD $99.00 + HST

Location

Online

Deadline

September 11, 2024

Workshop Overview

Data integrity is a cornerstone of quality assurance in any regulated industry. Reliable data is crucial for making informed decisions, ensuring compliance, and protecting patient safety. Unmanaged and inaccurate data can lead to severe consequences, including compromised product quality, regulatory non-compliance, and increased risks to patients. The FDA and other regulatory bodies have stringent expectations for data integrity, requiring firms to implement robust strategies to manage data integrity risks effectively.

This webinar provides a comprehensive understanding of data integrity principles, and preventing data integrity issues. Participants will learn about regulatory expectations, the key principles of ALCOA+, and review FDA warning letters. This webinar will help attendees develop a compliant data integrity program that safeguards their organization’s quality and compliance efforts.

Who Should Attend​

This workshop is designed for Quality Assurance professionals, Regulatory Affairs specialists, compliance officers, and anyone involved in data management within the pharmaceutical, food, or cannabis industries. It is particularly beneficial for those responsible for ensuring data integrity, managing data systems, and addressing regulatory requirements related to data integrity.

Workshop Outline

This workshop covers the following topics:

  • Understanding the definition and importance of data integrity
  • Reviewing regulatory expectations and frameworks for data integrity
  • Exploring the types and key principles of data integrity, including ALCOA+
  • Identifying common root causes of data integrity failures
  • Learning how to comply with FDA data integrity requirements
  • Analyzing FDA warning letters and 483s related to data integrity

Learning Outcomes

Comprehensive Understanding of Data Integrity

Develop a deep understanding of data integrity principles, their importance, and regulatory expectations.

Evaluating Compliance and Identifying Failures

Learn to evaluate data integrity compliance effectively and identify potential failures within your systems.

Designing Robust Data Integrity Systems

Gain practical knowledge on how to design systems that incorporate data integrity by design, preventing issues before they arise.

All participants will receive a certificate of attendance upon completion of the workshop.

Note: Registration closes one week prior to the start of workshop.

Fundamentals of Data Integrity

September 18, 2024

Other Workshops Available

Bilal Al-kadri

Pharma, Cannabis

Bilal Al-Kadri is a highly skilled Quality Assurance and Compliance expert with over two decades of proven leadership in the pharmaceutical, medical, veterinary, and cannabis sectors across North America and the Gulf region. As General Manager and Quality Assurance Person at EU Relief in Toronto, he spearheads all facets of cannabis operations, ensuring excellence in cultivation, processing, and regulatory adherence.

Recognized for his deep regulatory expertise, Bilal is proficient in Canadian GMP, cGMP (21 CFR Parts 210 & 211), Good Production Practices, ICH guidelines, ISO standards, and OSHA requirements. His extensive experience includes senior roles at top-tier organizations such as Sundial Inc. (Former Zenabis), CannaPiece, Summit Veterinary Pharmacy, and Apotex, where he led regulatory audits, product releases, CAPA systems, training initiatives, and the development of robust global quality systems.

Complementing his industry work, Bilal is also a dedicated educator, teaching advanced courses at AAPS. He holds a B.Sc. in Applied Chemistry and Biology, along with a post-diploma in Pharmaceutical Quality Assurance and Quality Control.