Sharpen Your Expertise with Targeted Technical Workshops

Pharmaconex 2025 presented three focused workshops designed to address key challenges in pharmaceutical operations: Data Integrity and Digital Batch Records: Streamlining Documentation in Generic Drug Production. Led by industry experts, these sessions offer practical insights and tools to enhance compliance, efficiency, and digital transformation in pharma manufacturing.

Data Integrity Workshop

Dive into the critical aspects of data integrity within the pharmaceutical industry in this intensive one-day workshop.

Gain a deep understanding of regulatory expectations, practical challenges, and strategic solutions essential to ensure data accuracy, security, and compliance.

This program seamlessly blends theoretical foundations with practical insights, empowering professionals to effectively manage and safeguard data throughout its lifecycle.

Program Highlights

Introduction & Overview
Understand the fundamentals of data integrity, its significance, and regulatory expectations.
Regulatory Frameworks & Guidelines
Explore the roles of key agencies such as the FDA, EMA, MHRA and get acquainted with essential regulations like 21 CFR Part 11, CGMP, as well as global standards including ISO guidelines.
Core Principles of Data Integrity
Master the ALCOA Fundamentals – Attributable, Legible, Contemporaneous, Original, Accurate – along with extended principles: Complete, Consistent, Enduring, and Available.
Data Lifecycle Management in Pharmaceutical Processes
Learn the critical stages of data handling: collection, processing, storage, and retrieval.
Challenges, Best Practices & Emerging Trends
Analyze digital system complexities, human factors, cybersecurity risks, audit trail gaps, and explore case studies that highlight remediation strategies and the impact of emerging technologies such as AI and Blockchain.

What You Will Learn

Comprehensive Knowledge
Develop a thorough understanding of data integrity principles and their application in the pharmaceutical industry.
Regulatory Compliance
Learn to navigate and adhere to regulatory frameworks and guidelines.
Lifecycle Mastery
Gain the skills needed to manage the complete data lifecycle from generation to archiving.
Problem-Solving
Identify and mitigate common challenges including cybersecurity threats and human error.
Future-Forward Thinking
Explore advanced technologies and emerging trends that are set to shape the future of data integrity practices.

Meet Our Instructor

Dr. Loice C. Kikwai is a pharmaceutical regulatory expert with 15+ years of experience in EMA, FDA, WHO, and ICH guidelines, specializing in generic drugs and bioequivalence. She has consulted globally, reviewed data for ANDAs and INDs, and authored industry guidance on clinical pharmacokinetic studies.

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Digital Batch Records: Streamlining Documentation in Generic Drug Production workshop

Join us for a specialized two-day workshop at Pharmaconex 2025 focused on the future of pharmaceutical documentation.
Led by industry experts, this session explores how digital batch records (DBRs) are transforming generic drug production by enhancing compliance, efficiency, and data integrity.

Program Highlights

Digital Batch Records Overview
Understand the role and benefits of DBRs in improving documentation and production workflows.
Regulatory Compliance
Explore expectations from EU, FDA, WHO, and PIC/S for electronic batch records.
ALCOA+ Principles
Learn how to apply data integrity standards in digital documentation.
System Features & Infrastructure
Identify key components of an effective DBR system and IT setup.
MES Integration
Discover how DBRs connect with Manufacturing Execution Systems for seamless operations.
Real-Time Monitoring & Analytics
Use data insights to enhance decision-making and troubleshoot issues.
Future Technologies
Get a glimpse of emerging tools shaping the next generation of digital documentation.

What You Will Learn

DBR Implementation
Learn how to set up and optimize digital batch record systems for pharma operations.
Regulatory Strategies
Understand how to meet electronic documentation standards from global authorities.
System & Infrastructure Setup
Gain practical guidance on selecting the right software and IT environment.
MES Integration Techniques
Explore methods for connecting DBRs with Manufacturing Execution Systems.
Monitoring & Troubleshooting Tools
Use analytics and real-time data to improve performance and resolve issues.
Future Innovations
Discover emerging trends shaping the future of digital documentation in pharma.

Meet Our Instructors

Omar Bader

Technical Compliance Consultant at Agon Pharmaceutical Consulting

Suhail Al Qarara'a

Technical Consultant at Agon Pharmaceutical Consulting

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NFSA regulatory framework - coding to market journey

This workshop, held in partnership with NFSA, offers manufacturing professionals the latest updates on Egypt’s regulatory framework for food supplements. Attendees will gain practical insights into registration processes, scientific review standards, and compliance strategies to navigate the market journey effectively.

Program Highlights

Introduction to NFSA’s regulatory framework and coding system
Step-by-step guidance on FSDU product registration
Scientific review sessions covering:
- Infant formula & herbal products
- Sports supplements & energy drinks
- Dietary supplements & fortified foods
Post-license services and inspection protocols