SOLD OUT: Quality in Manufacturing – August-September 2021 in Cleveland
August 31 @ 8:30 am - September 2 @ 3:30 pm
A risk management approach to pharmaceutical manufacturing quality standards under FDA guidance. Providing a thorough understanding of the manufacturing process to aid in QA activities such as Internal Audits, Deviation Investigations, Risk Assessments, Validation Activities, Complaint Investigations, Statistical Analysis. With a focus on Critical Equipment/Process Parameters on In-Process Test results and Finished Product test results.
Covering investigations for Validation, Calibration, Maintenance, Cleaning, Hold times, In-Process Testing. Variations in manufacturing controls and impact on tablet and capsule quality. This course will tour through all unit operations, including weighing, milling, blending, granulating, tableting, coating, and encapsulation. This course will provide action items to improve overall manufacturing quality throughout the entire solid dose process.
This class is limited to 10 people.
Who Should Attend:
Anyone in the manufacturing environment with a head for quality. Including all QA and QC personnel, Managers, Supervisors, including regulatory and compliance team members.
Course Fee :
This course fee will include a detailed course manual, personalized training certificate
- Single: $2,995 each
- 2-4 People: $2,595 each
- 5 or more people: $2,095 each
Day 1—8:30 am – 4:30 pm
- Intro to unit operations in solid dose manufacturing
- GMP in manufacturing
- Ingredient characterization and formulation quality implications
Day 2—8:30 am – 4:30 pm
- Regulatory requirements
- Weighing, Granulating, Milling, and Blending
- Tablet & Tooling Operations and Tablet coating
Day 3—8:30 am – 3:30 pm
- Defects & Solutions
- Summary / Q&A