6-Hour Virtual Seminar on CAPA (Corrective and Preventive Action), Failure Investigation and Root Cause Analysis

This webinar will examine the CAPA regulations, 21 CFR 211.198 (Pharma), 21 CFR 820.100 (Devices), Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and 21 CFR 822.

A more generalized "post market surveillance" / complaint handling is also a requirement under the CGMPs, 21 CFR 820, -.100 - CAPA, -.198 - Complaints, and 21 CFR 211.198 - Pharma Complaints. Data collected under manufacturing, complaints, and post-market surveillance, coupled with Failure Investigations and Root Cause Analysis, helps to address important public health questions on the safety and effectiveness of a product, often resulting in improvements in product development, manufacturing and distributione.

Why should you Attend: Global companies must meet US FDA 21 CFR 820 (The device QSR) or 21 CFR 211 (pharmaceuticals)) requirements in order to sell such products in the US, no matter where they are manufactured. One of the principal components of those requirements is CAPA for finding, addressing and solving non-compliances. These companies must pass FDA compliance inspections (audits) to the Regulatioins / Laws.

Addressing post-market use issues and complaints is also a major activity of a CAPA system. The FDA expects companies to have effective programs in place to capture post-market problems / non-conformances, react to minimize risk to users / patients, and use such data for product improvement.

CAPA requires effective Failure Investigations and Root Cause Analysis. Tools? How does failure to comply result in adulterated product, 483 Observations, Warning Letters, and worse. What are key components of a CGMP-compliant CAPA system? Where does required Adverse Events Reporting to the FDA fit into such a system? This six hour seminar will provide suggested and mandated approaches, and the answers to these and other related questions.

Agenda:

• The Device CGMPs and ISO 13485 on CAPA
• The Pharma CGMPs on CAPA
• 21 CFR 822, FD&C Act Section 522
• FDA Guidance Documents' Recommendations
• Product Risk Management, and applicable Human Factors / Use Engineering
• Production and Process Controls
• CAPA Implementation, Usage and Documentation
• Failure Investigation and Root Cause Analysis
• The Risk Management File (ISO 14971) and its role
• The Use Engineering File (IEC 62366-1) and its role
• Expected QMS Records

• Senior Management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• All Personnel involved in the U.S. FDA-Regulated Medical Drug or Device Development, Manufacture, and Post Market Activities. Especially those involved in Product Development, Non-Conformancess and Field Problems / Complaints, Line Extensions, and Incremental Product Improvements; having to evaluate those changes in light of the DHF / CGMPs, and then document these actions in harmony with the regulations