This course is a part of the API Professional Series courses and includes a certification number once all requirements have been met. It covers the entire Q1 Body of Knowledge (BOK), including: scope; exclusion; documentation; organizational resource requirements; product and process realization; purchasing; design for services; service execution; control of products; testing, measuring, monitoring and detection equipment; risk assessment, internal audits, control of nonconformities, management reviews, etc.. In addition, this course covers the objectives, intent and application of the elements and has an in-depth review of the controls and requirements associated with risk assessment and management; contingency planning; product quality plans; and management of change. The course covers the five new sections and 85 additional clauses from a manufacturing point of view.
CONTENT
- Risk assessment and management
- API Monogram Program
- Contingency planning
- Product Quality Plans
- Management of change (MOC)
- Internal audits
- Corrective action and root cause analysis
- Annex A
BENEFITS
At the conclusion of this course, successful attendees will have been provided with:
- A thorough understanding of the API Monogram Program
- An understanding of Product Quality Plans
- An understanding of risk assessment and management.
- The ability to plan, conduct and report process based audit activity
- The importance of meeting customer requirements and achieving customer satisfaction
- Real world knowledge and examples from some of our most experienced API Q1 auditors/instructors.
PREREQUISITES
None, however, a familiarity with the ISO 9001 standard would be beneficial.
CERTIFICATE & LENGTH
This is a four-day course. Successful attendees will receive a USQC Training course certificate of completion.
COURSE SETTING
Continental breakfast and lunch will be provided for you each day of the course, plus all day refreshments. Dress is casual to business casual, you only need to bring yourself, as we provide all course materials, including pens and paper. Courses are generally held in a hotel meeting room venue and we obtain discounted pricing on hotel sleeping rooms, which we pass on to you.
discounts
Pricing discounts are available for multiple attendees from the same company or group