Certifications and Training

A consolidated record of academic degrees, professional certifications, and continuing education that supports the pharmaceutical automation and GxP validation practice.

Academic degrees

MEng in Industrial Automation, Hanoi University of Science and Technology (HUST). Thesis on ISA-95 integration for batch processes. BEng in Automation and Control Engineering, HUST.

Professional certifications

Certified Automation Professional (CAP) — ISA, 2017. AVEVA PI System Administration — AVEVA, 2020. Vendor training: Tulip Frontline Operations, OPC-UA, Rockwell FactoryTalk, Siemens SIMATIC PCS 7, Schneider EcoStruxure.

GxP and regulatory training

GAMP 5 Risk-Based Validation — ISPE, 2019. 21 CFR Part 11 Compliance — ISPE, 2020. EU GMP Annex 11 — ISPE, 2020. ALCOA+ Data Integrity — MHRA/ISPE, 2021. FDA Computer Software Assurance (CSA) Draft Guidance — ISPE, 2022. EU GMP Annex 1 — ISPE, 2023. Vietnam GMP Inspector Training Observer — MOH Vietnam, 2022.

OT/IT and cybersecurity

IEC 62443 OT Cybersecurity Fundamentals — ISA, 2022. ISA-95/IEC 62264 Enterprise-Control System Integration — vendor training, 2019. ISA-88 Batch Control — vendor training, 2018.

Memberships and continuing education

ISPE member since 2018. PDA member since 2019. Active in ISPE Communities of Practice (GAMP, Pharmaceutical Engineering, Data Integrity), PDA Letter and Technical Reports, ISA standards updates, and continuing education on AI/ML for pharmaceutical manufacturing.

How to use this page

Use this Certifications and Training page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.

Evidence to prepare

For Certifications and Training, prepare the records, owners, risks and decision criteria linked to academic degrees, professional certifications, gxp and regulatory training, ot/it and cybersecurity, memberships and continuing education. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.

Frequently asked questions

What is Nam Pham's primary academic background?

MEng and BEng in Automation and Control Engineering / Industrial Automation from Hanoi University of Science and Technology (HUST).

Is Nam Pham ISPE certified?

ISPE member since 2018, with active participation in GAMP, Pharmaceutical Engineering, and Data Integrity Communities of Practice. Several ISPE training certificates (GAMP 5, 21 CFR Part 11, Annex 11, CSA).

Does Nam Pham hold any vendor certifications?

Yes: Certified Automation Professional (ISA), AVEVA PI System Administration, plus training in Tulip, OPC-UA, Rockwell FactoryTalk, Siemens SIMATIC PCS 7, and Schneider EcoStruxure.

How can clients verify the credentials?

Contact via /contact with the specific credential name and reason for verification. All credentials are backed by the issuing organization's records.