The pharmaceutical, biotechnology, and therapeutic goods sectors operate within complex regulatory frameworks that demand stringent adherence to Good Manufacturing Practice (GMP), quality assurance protocols, and data integrity standards. Yet, despite significant investment in infrastructure and systems, many organisations continue to struggle with internal communication barriers and functional silos. These silos often hinder cross-functional collaboration, reduce organisational agility, and ultimately compromise compliance and product quality.

On May 30th, the QSN Academy, the dedicated training division of Quality Systems Now, will deliver a specialised webinar titled "Breaking Silos: Building Cross-Functional Compliance Competence." Designed for regulatory, quality, production, and laboratory professionals working within GMP-regulated environments, this session will examine the root causes of departmental silos, their impact on compliance performance, and practical strategies to overcome them.

This article outlines the scientific and compliance rationale behind the Breaking Silos initiative and how this webinar supports therapeutic goods manufacturers, biotechnology organisations, and testing laboratories in enhancing their organisational effectiveness.

The Compliance Cost of Silos

Functional silos refer to isolated departments or units within a company that operate with limited communication, visibility, or collaboration with other groups. In GMP-regulated environments, the consequences of silos extend far beyond inefficiencies—they pose serious compliance risks.

Silos often result in:

• Inconsistent interpretations of regulations and SOPs

• Duplication of work or incomplete documentation

• Delayed deviation investigations and CAPA implementation

• Fragmented risk assessments

• Inadequate training alignment between departments

For example, when Quality Assurance (QA) and Production do not share a common understanding of contamination control strategy, the resulting procedures may be misaligned or misunderstood, leading to audit observations or batch rejections. Similarly, when Regulatory Affairs is not informed of a process deviation, incorrect or incomplete information may be submitted in variation applications.

The Importance of Cross-Functional Competence

Cross-functional competence is the ability of individuals and teams to operate with an awareness and understanding of how their actions and responsibilities affect—and are affected by—other functions within the GMP ecosystem. This is not merely about interdepartmental collaboration, but about a systematic integration of compliance goals, terminology, and processes across business units.

The Breaking Silos webinar focuses on fostering this competence through training that is:

• Contextualised to GMP and regulatory requirements

• Role-sensitive to the differing perspectives of QA, QC, Manufacturing, Engineering, and Regulatory teams

• Scientifically grounded in risk management and process validation principles

• Regulator-aligned with PIC/S, TGA, and global best practices

Participants will gain practical skills in recognising silo behaviours, implementing cross-functional workflows, and creating shared compliance metrics that drive unified performance.

Scientific and Regulatory Foundations

The challenges posed by functional silos are acknowledged in several international guidance documents. For instance:

• ICH Q10 emphasises the role of cross-functional teams in pharmaceutical quality systems

• PIC/S PE009-17, Chapter 1, requires “defined responsibilities and inter-departmental communication” as fundamental to effective quality management

• EU GMP Annex 1 (2022 revision) stresses the need for holistic contamination control strategies that involve quality, engineering, and operations functions

• TGA expectations during GMP inspections often highlight the necessity for consistent communication between production, QC, and quality units

The Breaking Silos webinar will discuss case studies and regulator findings where inadequate cross-functional integration contributed to GMP non-compliance, offering participants real-world examples of the risks and remedies.

Webinar Objectives

The primary objective of the Breaking Silos webinar is to enable GMP professionals to develop the skills, mindset, and strategies required to reduce the negative impact of functional silos on compliance and product quality. By the end of the session, participants will be able to:

1. Identify common silo behaviours in their own organisations and assess their impact on compliance outcomes

2. Understand the role of shared risk management and quality metrics in fostering alignment between functions

3. Implement cross-functional process mapping to clarify responsibilities and improve documentation flow

4. Develop communication protocols and training approaches that span departments and functions

5. Apply root cause analysis and CAPA processes that consider cross-functional interactions

6. Build a compliance culture that supports transparency, knowledge-sharing, and continuous improvement

These objectives are framed within the scientific context of systems thinking and operational excellence in regulated industries.

Who Should Attend?

The webinar is specifically tailored for professionals involved in GMP and regulatory compliance activities, including but not limited to:

• Quality Assurance Managers and Officers

• Regulatory Affairs Specialists

• Manufacturing Supervisors and Technicians

• QC Analysts and Laboratory Managers

• Validation Engineers and Project Managers

• Compliance Officers and GMP Auditors

The session is particularly relevant to organisations undergoing system upgrades, new product introductions, or responding to recent regulatory inspection outcomes.

Training Methodology and Format

QSN Academy’s training methodology is grounded in adult learning principles and scientific instructional design. The Breaking Silos webinar will incorporate:

• Live instruction by experienced GMP and regulatory professionals

• Interactive case scenarios based on real industry challenges

• Polls and chat-based discussions to promote engagement

• Practical tools and templates for post-webinar application

• Live Q&A to address participant-specific challenges

The training is delivered online to enable participation from teams across Australia and New Zealand. All participants will receive a certificate of completion, along with access to supplementary resources.

Organisational Benefits of Attending

Organisations that participate in the Breaking Silos webinar can expect to see:

• Improved compliance robustness through integrated decision-making and documentation

• Reduced audit findings related to procedural misalignment or inconsistent records

• Enhanced deviation management and CAPA effectiveness

• Faster project delivery timelines due to clearer interdepartmental communication

• Stronger training and onboarding programs that reflect holistic GMP operations

Ultimately, breaking silos is not just about efficiency—it is about protecting patients by ensuring that the entire organisation works in unison to uphold the highest standards of product quality and regulatory compliance.

Conclusion

As regulatory expectations grow and GMP environments become increasingly complex, the risks associated with departmental silos cannot be ignored. Training and awareness are essential first steps in building a culture of cross-functional competence and accountability.

The Breaking Silos webinar by QSN Academy on May 30th offers a unique opportunity for professionals across the therapeutic goods industry to learn how to dismantle silos, align compliance objectives, and work collaboratively toward shared quality goals.

We invite you to join us in this vital conversation and take the first step toward building a more integrated, compliant, and high-performing organisation. Visit https://qualitysystemsnow.com.au/webinar-breaking-silos to register and secure your spot today.