PTI - international

Improve your ability to:

• Apply validation to PLC, SCADA and DCS and avoid regulatory consequences

•  Implement software lifecycle models and activities to avoid serious problems later in the development process

• Meet documentation requirements for automated process controls and maintain regulatory compliance

• Assess FDA philosophy towards software testing to help adequately prepare for inspections

• Confront change control issues (PLC maintenance, SCADA upgrades) to avoid 483s and warning letters

• Revalidate outdated systems and mature equipment received from other sources to ensure a consistent quality of your product

• Respond to the urgent request for compliance documentation and prevent time and money consuming delays

• Analyze common FDA observations and be fully ready to create your own real life responses

• Examine vendor audit issues to sidestep common audit pitfalls

• Explore ER/ES - 21 CFR Part 11 compliance issues to clarify the scope of FDA expectations

PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-04-092-L04, Initial release: 04/04.