Training Course Syllabus:
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations
It is no surprise to anyone who reviews regulatory citations to notice the number of deficiencies cited that are associated with quality systems. Today, the basis for all FDA audits both within the US and internationally is based on the quality systems approach and the six systems that comprise it. Whether the audit is a full or partial audit, the quality system within a company will always be inspected and this seminar will help review what are the expectations and the common areas to be familiar with. As a basis for regulatory audits, the quality system, its procedures and their implementation are reviewed to help verify the level of effectiveness in assuring consistent control and quality of materials, components and final product.
This training will examine the differences between Quality Assurance and Quality Control and the responsibilities of each. In addition, attendees will discuss what characteristics quality personnel should possess. The current expectations for an effective quality system program as defined in both the FDA and EU requirements and guidance documents will be reviewed. Topics to be covered will range from the development of a quality manual and procedures, the importance and scope of audits (internal, vendor, third party and regulatory) along with review of various case studies to help further illustrate points discussed.
The quality department within companies is responsible for nearly all activities to various degrees that have impact on the quality, safety or efficacy of the final product or material produced. It is also responsible for helping assure that contracted services, which is more common today than ever before, are also verified to meet the quality standards set both by the company and the regulatory requirements. The training will review special topics of interest to auditors such as CAPA programs and investigations that address deviations and out of specification (OOS) results. Attendees will be given ample opportunity to ask questions, discuss actual case studies and to learn about the vast scope of responsibility that the quality system regulations expect and the roles of their own positions..
Upon completing this course participants should:
Understand the regulatory expectations of the quality unit and its role in the Quality System Requirements (QSR)
Review the Quality areas that are the point of focus during regulatory, corporate or third party audits.
Review typical checklist that can be used as a template for the performance of audits
Evaluate the importance of training, its documentation, and common concerns being raised over "operator error"
Review the importance and regulatory guidance offered for the investigation of deviations/out-of-specification results.
Review the current focus on data integrity issues and the current guidance document regarding it
Review the top 10 most commonly cited drug GMP deficiencies for 2015-2016
Understand the weaknesses of each personīs current quality system and discuss possible recommended corrective actions
DAY 01(8:30 AM - 4:30 PM)
Registration Process - (8:30 am till 8:45 am)
Review of Regulatory requirements for the quality organization within companies. Will examine current FDA (21 CFR parts 210-211 and 820), EU and Health Canada requirements.
Discuss the importance of audits as a means of assuring compliance and the ability of the Quality System to meet its responsibilities.
Review importance of internal and vendor audits and provide a checklist of items to be covered and reviewed. Discuss expectations for applicable procedures covering these topics.
Discuss audit techniques that will help assure successful results when preparing for audits.
Review current industry guidelines for the investigation of "Out-of-Specification" (OOS) laboratory results.
Review current FDA Guidance document dealing with data integrity and issues that companies should implement.
DAY 02(8:30 AM - 4:30 PM)
Discuss areas of concern and focus during laboratory audits.
Review importance and requirements for personnel training.
Discuss current concerns by FDA and EU auditors regarding "operator error" when listed as the "root cause" for deviation investigations.
Review importance and requirements for vendor evaluations and quality agreements. What to look for, what to be included, etc. Discuss actual case studies as to actions taken by vendors and their potential impact on component, service or product quality.
Discuss importance of CAPA process and change control programs that help maintain compliance and prevent occurrences of deviations.
Review the 10 most common drug GMP deficiencies cited by the FDA inspectors during 2015-2016. Learn what quality systems are found most deficient.