Training Agenda

Beyond Compliance: Building a

Culture of Data Integrity

Speaker: Eng. Safwa Al-Musa

Co-Speaker: Eng. Mohammad Awawdeh
Date: 18 February 2025

Arranged By
Pharada and Al Massat

PHARADA Al MASSAT LIFE SCIENCES

Background Target
In the rapidly evolving Audience
• This training is ideal for
pharmaceutical industry, data professionals involved in
integrity remains a cornerstone of ensuring data integrity and
compliance and product quality. compliance in the pharmaceutical
Regulatory authorities worldwide, industry, including:
including WHO, FDA, EMA, and • Quality Assurance (QA) and
PIC/S, have emphasized the critical Quality Control (QC)
• Regulatory Affairs Specialists
importance of maintaining data
• IT and Data Management Teams
integrity throughout the product
• R&D and Production Teams
lifecycle. This training aims to
• All employees in operations,
provide participants with the
quality, and research roles within
knowledge and tools to navigate the
the pharmaceutical industry.
complexities of data integrity and
foster a culture of compliance within
Objectives Outcomes
their organizations.
• Understand the importance of • Clear understanding of data
data integrity and ALCOA+ integrity principles and
principles. regulations.
• Learn global regulatory • Ability to identify and address
requirements (WHO TRS 996, ICH data integrity risks.
Q7/Q10, PIC/S). • Enhanced skills for audit
• Assess and mitigate data readiness and compliance.
integrity risks. • Practical knowledge of tools for
• Apply best practices for data maintaining data integrity in
lifecycle management. paper-based and computerized
• Leverage digital tools for data
systems.
integrity. • Focus on fostering a culture of
• Explore digitalization in
accountability and excellence.
validation processes.
Regulations Contact
• Develop practical strategies
Thisthrough
training iscase studies
based and
on key regulatory Pharada
frameworks and
exercises. guidance documents, 401, 4th floor, Al Hazim Center
including: Yajouz Rd, Al Jubaiha
• WHO TRS 996 Annex 5: Guidelines on
Amman, Jordan
ensuring data integrity in pharmaceutical
quality systems.
Phone: +962 79 8058346
• ICH Q7/Q10: Good Manufacturing Practice [email protected]
(GMP) and Pharmaceutical Quality www.pharadaconsult.com
Systems (PQS).
• ISPE GAMP5: A risk-based approach to Al Massat Life Sciences Egypt
compliant computerized systems. Al Yasmeen 7 – Villa 359
• PIC/S PI-041-1: Good Practices for Data New Cairo, Egypt
Management and Integrity in regulated Phone: +202 23097751
environments.
• FDA 21 CFR Part 11: Electronic records
Mobile: +20 109 157 2227
and electronic signatures compliance. [email protected]
www.maskem.com
Participants will gain a comprehensive
understanding of these regulations and how
to implement them effectively in their
operations.
Beyond Compliance: Building a
Culture of Data Integrity

Introduction to Data Integrity Overview of regulatory ecosystem

• Importance of data integrity in

Overview of Regulatory and
pharmaceutical operations.
recognized references WHO TRS
• Evolution of regulatory
996 Annex 5, ICH Q7/Q10, ISPE
expectations for data
GAMP5, ISPE GAMP Guide:
management.
Records & Data Integrity, and
• Overview of Data integrity
PIC/S PI-041-1
Principles
Data Governance Data Integrity Principles and Enablers

• Data governance systems and

ALCOA+ principles.
their structure. Practical applications.
• Risk management approach.
Tools and enablers for
• Data criticality, risk, and
sustainable compliance.
governance system reviews. ALCOA + implementation practice

Specific Data Integrity Considerations Case Study

for Paper-Based Systems
Lessons from failures in paper-
• Structure of the
based systems.
Pharmaceutical Quality

System and control of blank

Organizational Influences on Data
forms/templates/records. Integrity Management

• Importance of controlling
• Organizational values, quality
records: generation,
culture staff conduct, and
distribution, retention, and
ethics.
disposal.
• Modernizing the
• Expectations for point-of-use
Data Integrity in Quality Control Pharmaceutical Quality
records and verification
Laboratory
System.
processes.
Practical Examples • Management review and

resource allocation.
• Addressing internal issues.
Beyond Compliance: Building a
Culture of Data Integrity

Specific Data Integrity Considerations

Data Integrity Risk management
for Computerized Systems
• Structure and control of • Integrating data integrity into
computerized systems. Quality Risk Management
• Validation lifecycle of (QRM).
computerized systems. • Conducting effective risk
• System security and access assessments.
control. • Prioritizing mitigation efforts.
Data Integrity in Outsourced Activities
• Data transfer, backup and

retrieval. • Strategies for assessing

• Excel spreadsheets, and supply chain data integrity.

blockchains. • Routine document verification.

• Audit trails
Management of Hybrid Systems • Developing contracts and

• Storage , archival and disposal monitoring outsourced

• Controls and Procedures
of electronic data activities.
• Risk management Investigating and Addressing Data
Integrity Breaches

Regulatory Actions in Response to Data • Steps for investigating

Integrity Findings
suspected data integrity
• Deficiency in references and issues.
classifications. • Implementing CAPA for
• Examples of regulatory remediation and prevention.
actions. • Indicators of improvement.
• Best practices for addressing

regulatory observations.
• Examples
Ensuring Continuous Data Integrity
Compliance
Group Activity: Developing a data

integrity compliance roadmap.

 Workshop
Leaders
About the Speaker: Eng. Safwa Al-
Musa
Founder of Pharada for Consultation and Project Management

ISPE Middle East Affiliate Steering Committee Member

AUPAM Scientific Committee Member

Eng. Safwa Al-Musa has over 30 years of diversified hands-on experience in

the pharmaceutical industry. She is a prominent trainer and consultant
specializing in quality, regulatory, and strategy-related topics, having
delivered numerous trainings and consultations across Jordan, Palestine,
Saudi Arabia, Kuwait, Egypt, Sudan, Eritrea, India, and Thailand.

She has successfully supported companies in building quality management

systems and preparing for GMP inspections by recognized authorities. Her
current focus is on helping organizations establish sustainable growth
strategies through integrated transformation programs and cultural
excellence initiatives that enhance organizational maturity, ensuring the
achievement of quality objectives for the benefit of customers and
patients.

About the Co-Speaker: Eng. Mohammad

Awawdeh
Eng. Mohammad is a seasoned professional with a diverse background in roles like
Validation Supervisor, Senior Engineer, and Consultant.

With a robust history of spearheading validation projects for advanced systems and
processes, their expertise encompasses:
• Developing and managing validation protocols and reports for complex projects.
• Overseeing validation for equipment, computerized systems, HVAC, and
production processes.
• Ensuring regulatory compliance through rigorous validation and calibration
methodologies.
• Providing training sessions and consultation services to elevate team
performance and drive quality excellence.

Eng. Mohammad's commitment to innovation and continuous improvement, coupled

with their hands-on approach, ensures data integrity and compliance, enabling
organizations to achieve superior operational standards.