Effective auditing of Manufacturing and Quality systems and assets is an essential part of all quality management systems (QMS). The regulations and GMPs clearly require that we evaluate and audit our operations in several ways:
• Annex 15 ‘Qualification and Validation’ clearly requires a process of audit and review of designs against the URS and GMP requirements and best practice. This is called Design Qualification (DQ) or enhanced design review.
• Internal self-inspection and audit is an essential part of continuous improvement.
• We are required to audit suppliers (Contract manufacturers, APIs suppliers, and providers of materials and components).
• We need to prepare for regulatory inspections and B2B audits.

Inspectors & Auditors are often short of time and may not be expert in every part of a manufacturing and quality operation. To help guide attendees the course will include:
• The GMP requirements for HVAC and important Critical Utility Systems.
• The importance of effective Commissioning & Qualification.
• Some important industry trends and best practices.
• Guidance on common issues and problems (what to look for!).
• How to sense problems.
• Questions to ask.
• Planning ahead of the audit.

The main content of the course will be:
• The role and importance of effective Commissioning and testing of Pharma HVAC Systems
o NEBB best practices.
o Using tests in ISO 14644-3 and IEST RP006 test methods.
o Leveraging commissioning data for qualification – How to avoid duplication of testing.
o Monitoring performance.
o Auditing systems.

• General requirements for auditing:
o Industry and regulatory trends and developments.
o Planning an audit.
• For auditing each type of system:
o What documentation should be requested. Data, Drawings, diagrams, etc.
o What visual inspection access should be requested?
o Audit check-lists.
o Common faults, problems and issues – things to look for.
o Guidance on understanding technical drawings P&IDs, layouts, etc.
o Getting information from ‘deviations’ or ‘quality events’, EM data and information, change control, and operational failures.

Auditing, HVAC system, utilities system, quality management system, Design Qualification, NEBB, ISO14644

1. Online Registration Browse website http://ispeth.org/EVENT-2_2019, fill-in delegate details and click submit 2. Confirmation ISPE staff will confirm your registration status via email. If not receive email within 2 working days after submitted the form, please contact our staff. 3. Payment Make a payment to reserve your seats and capture/ scan transferred evidents i.e. payslip to email REGISTER@ISPETH.ORG REGISTRATION CLOSES ON 4 MAY 2019 OR WHEN ALL SEATS ARE FULLY RESERVED. FIND OUT MORE INFO & CONTACT US: WWW.ISPETH.ORG EMAIL: REGISTER@ISPETH.ORG T: +6688-090-4664 PAYMENT Payment must be received prior to the event otherwise the reservation will be cancelled. All payments should be made in Thai Baht. BANK > KASIKORN BANK, LAD PRAO 67 BRANCH ACCOUNT > ISPE FOUNDATION NUMBER > 027-8-46566-7 SWIFT CODE > KASITHBK BANK ADDRESS > 2347 LADPRAO 67, WANGTHONGLANG, BANGKOK, THAILAND 10310