Two of our Senior Directors, Andy Hopkins and Bob Wittorf, will be speaking at PDA events in Singapore this May 2026, sharing practical regulatory insight on some of today’s most critical pharmaceutical manufacturing and quality topics.
These PDA events bring together global regulators, industry leaders, and technical experts to address evolving expectations for manufacturing, contamination control, and compliance. Lachman Consultants is excited to contribute thought leadership grounded in real-world inspection experience and global regulatory engagement.
PDA Pharmaceutical Manufacturing and Quality Conference 2026
Singapore | 12–13 May 2026
The PDA Pharmaceutical Manufacturing and Quality Conference 2026 will address current and emerging challenges across pharmaceutical manufacturing and quality systems, with a strong focus on global regulatory expectations.
Andy Hopkins, Senior Director
Session: WFI by RO: Background and Concerns
The use of reverse osmosis (RO) for Water for Injection (WFI) continues to gain global regulatory acceptance, while raising important questions around system design, validation, and long-term control. In this session, Andy Hopkins will explore:
- The regulatory evolution supporting WFI by RO
- Key differences between distillation- and RO-based WFI systems
- Technical and compliance risks associated with RO systems
- Validation, monitoring, and lifecycle maintenance considerations
- Common inspection observations and lessons learned
This session will provide attendees with a clear understanding of regulator expectations and practical strategies for maintaining compliant, reliable WFI systems.
Bob Wittorf, Senior Director
Session: Annex 1 Applicability to Bulk Drug Substance Manufacturing
With the revised EU GMP Annex 1 now firmly embedded in regulatory expectations, manufacturers of bulk drug substances are continuing to assess how its requirements apply to dosage forms that are considered non sterile but still require microbial controls during process e.g. low bioburden biological drug substances.
In his presentation, Bob Wittorf will address:
- How Annex 1 expectations apply to bulk drug substance manufacturing
- Areas of interpretation and common misunderstandings
- Risk-based application of contamination control principles
- Practical implications for facility design, operations, and quality systems
- Inspection trends and regulatory expectations
This session will be especially valuable for organizations seeking clarity on Annex 1 applicability beyond traditional sterile finished product manufacturing.
PDA Microbiology in CCS Workshop 2026
Singapore | 14 May 2026
Following the conference, Andy Hopkins will also speak at the PDA Microbiology in CCS Workshop 2026, a focused technical workshop dedicated to contamination control strategies (CCS) and microbiological risk management.
Workshop Topic: Challenges in Cleanroom Installations and Maintenance
Cleanroom performance is foundational to effective contamination control, yet installation and maintenance challenges remain a recurring root cause of compliance issues.
In this workshop, Andy will discuss:
- Common pitfalls in cleanroom design and installation
- Construction and execution issues that introduce contamination risk
- Commissioning, qualification, and requalification challenges
- Maintenance practices impacting long-term cleanroom performance
- Aligning cleanroom management with CCS and regulatory expectations
Attendees will leave with practical, experience-based insights to strengthen cleanroom control and inspection readiness.
Connect with Lachman Consultants in Singapore
Lachman Consultants supports pharmaceutical and biotechnology companies globally in navigating complex quality, manufacturing, and compliance challenges across the product lifecycle.
If you are attending either PDA event, we encourage you to participate in our sessions and connect with our team to discuss your specific regulatory or operational needs. We look forward to seeing you there. To set up a time to meet, please contact us here.
