On-Site KGMP Training Program for Manufacturing Quality Teams

About This Program

A 3-day on-site KGMP training program delivered at the manufacturer's facility (or at a regional venue for multi-site organizations). The program is specifically structured for production floor leaders, quality assurance staff, and regulatory affairs members who will be the front-line responders during KGMP certification or surveillance audits.

The program is not a generic ISO 13485 refresher. It is Korea-specific, scenario-driven, and built around the actual situations KGMP auditors create during on-site visits to foreign-manufacturer facilities.

Who This Is For

• Quality and production staff at manufacturing sites preparing for first-time KGMP certification
• Sites preparing for 3-year surveillance audits or recertification audits
• New QA hires at sites with existing KGMP certification
• Cross-functional teams (production, QA, RA, engineering) wanting shared baseline understanding

The program is delivered in English with Korean translation available for Korean-speaking staff. Materials are bilingual.

What You Will Learn

Day 1: KGMP Framework and Site Readiness

• The KGMP regulatory framework: how it relates to ISO 13485 and what is uniquely Korean
• The three KGMP audit types (document-only, on-site, accredited body survey) and how each is conducted
• The KGMP certificate lifecycle: certification, surveillance, recertification
• Site readiness self-assessment: a structured walkthrough of the participant's facility against KGMP scope
• The Korean Quality Manual: structure, content, common gaps
• Document control overlay requirements for KGMP

Day 2: Process Areas Auditors Focus On

• Design controls: traceability expectations from user needs to verification evidence
• Supplier control: the audit specifics around approved supplier lists, supplier audits, supplier change control
• Sterilization validation: documentation expectations for sterile devices
• Manufacturing process validation: IQ/OQ/PQ evidence specific to KGMP
• Complaint handling: the Korean-specific routing through the KLH
• Adverse event reporting: the 7/15/30-day clocks under the 2026 framework
• Internal audit: how to structure internal audits to surface KGMP findings before external auditors do

Day 3: Audit Day Behavior and Findings Response

• The opening meeting: what to expect and how to set the tone
• Audit room logistics: documents accessible, personnel availability, interpreter coordination
• Process walkthroughs: what auditors observe and what they ask
• Personnel interviews: who gets interviewed, how to prepare them
• Document sample pulls: how to respond to record requests within the 15-minute window
• The closing meeting: receiving verbal findings, asking clarifying questions
• The 48-hour findings response window
• CAPA development for findings: structure, timelines, evidence

The program combines lecture content (typically 40% of time) with hands-on workshop activities (60%) — scenario walkthroughs, mock audit interviews, document review exercises using the participant's actual records (with confidentiality protocols).

Program Format

Standard format:

• 3 consecutive days (typically Tuesday–Thursday or Wednesday–Friday)
• On-site at the manufacturer's facility
• 8–16 participants (smaller groups produce stronger learning outcomes)
• Bilingual delivery (English + Korean translation)
• Materials provided in advance for pre-reading
• Take-home reference materials including the KGMP audit checklist

Customized format options:

• Compressed 2-day format for sites with very limited time availability
• Extended 4-day format incorporating a full mock audit on the last day
• Multi-site delivery for organizations with multiple manufacturing locations
• Remote delivery (synchronous virtual) for sites where on-site is not feasible

Pre-Program Preparation

Participants are asked to:

• Review the participant's current ISO 13485 Quality Manual before the program
• Pull a recent CAPA, complaint, and design change record (for use in workshop exercises, under confidentiality)
• Identify 3 questions or concerns about KGMP that the team wants to address during the program
• Reserve uninterrupted attendance — the program is hands-on and absence significantly reduces value

A pre-program 30-minute call with the Leanabl team scopes the participant's specific context (product type, audit history, target audit timeline) so the program content is calibrated to actual situation rather than delivered generically.

What Participants Leave With

Concrete deliverables from the 3-day program:

• Bilingual KGMP audit checklist customized to the participant's product scope
• KGMP-specific document checklist with mapping to current QMS documents
• Mock audit findings list from the workshop exercises (typically 5–15 findings to remediate)
• A 12-week action plan derived from the mock findings
• Reference materials: KGMP regulatory text in Korean and English, audit observation logs from prior engagements
• Direct contact channels with Leanabl Korea QA leads for post-program questions

Continuing Support

The 3-day program is the foundational delivery. For sites wanting ongoing support:

• 4-week post-program follow-up call (included in standard delivery)
• Quarterly Korea QA reviews (separately engaged, with sites in active KGMP cycles)
• Just-in-time audit support: dispatched Leanabl QA lead for the actual KGMP audit days (separately engaged)
• Integration with the Korea Audit Readiness solution for sites wanting full audit preparation rather than self-directed remediation

Why This Format Works

A few observations from running this program across many sites:

• On-site delivery, in the manufacturer's actual facility, produces meaningfully stronger learning than off-site or virtual delivery. Participants connect the content to their real environment.
• Cross-functional attendance (production + QA + RA together) produces shared mental models that single-function attendance cannot replicate.
• Workshop-style scenarios using the participant's actual records (CAPAs, complaints, design changes) generate immediate practical learning that abstract case studies do not.
• The bilingual format is essential for foreign-manufacturer sites with Korean-speaking staff who interact with auditors. The translation is not an accommodation; it is operationally necessary.

How to Schedule

Programs are scheduled based on site availability and Leanabl Korea team calendar. Typical lead time is 8–12 weeks from initial inquiry to delivery. For urgent audit-preparation situations (audit notice received with short timeline), expedited scheduling is sometimes possible.

Where This Connects to Broader Engagement

For sites where the 3-day training is the right starting point but the team needs additional support to be audit-ready, the program is often paired with:

• Korea Audit Readiness — for hands-on preparation rather than self-directed work
• KGMP Certification — for first-time certification programs
• Korea License Maintenance — for ongoing surveillance audit support

Many sites use the on-site training as the start of a longer engagement. The training is the entry point; the deeper work follows when the team has the shared baseline.

Where Leanabl Plugs In

This training is part of the Training service offering, with delivery by Leanabl Korea QA practitioners. For broader regulatory and quality training beyond KGMP, the Training service runs structured programs across multiple regulatory frameworks. The KGMP-specific work integrates with Korea QMS Foundation, KGMP Certification, and Korea Audit Readiness.