Industries: Pharma / Biotech

Product Quality Reviews

Course Director: Jerry Lanese , Ph.D.

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

Course Brochure: Product Quality Reviews

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU and Canada. If used effectively, these reviews can be a powerful Quality Assurance tool. The Product Quality Review Process includes: Process Performance and Product Quality Monitoring, Corrective Action/Preventive Action, Change Management and Management Review which are enablers identified in ICH Q10, The Pharmaceutical Quality System. It also includes the ICH Q10 enablers of Knowledge Management and Quality Risk Management. Contemporary guidance suggesting that the Annual Product Review can support the concept of Continued Process Verification and Quality Metrics.

The purpose of the annual product quality review course is to educate the participant in the regulatory requirements for the FDA Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as a Quality Assurance and Quality Improvement tool. We will discuss how the Product Review supports the US, EU and Canadian GMPS while applying the ICH Q10, Pharmaceutical Quality System elements of Process Performance and Product Quality Monitoring, CAPA, Change Management and Management Review, as well as the enablers of Information Management and Risk Management. Discussion will also include the impact of the FDA 2011 Process Validation guidance and the potential impact of the proposed FDA requirement for Quality Metrics on the Product Review.

Topics of discussion include:

  • The regulatory requirements for the Annual Product Review
  • The Annual Product Review as it relates to other required and expected reports
  • The Annual Product Review as part of a contemporary Quality System
  • What should be included in the Product Review
  • The Product Review as a source of recommendations for process improvement
  • Management involvement and responsibility
  • The Product Review in support of stage 3 of process validation, continued process verification
  • The Product Review process as a user of, and contributor to, the corporate knowledge
  • The application of quality metrics to the Product Review process

FDA Annual Product Review training course participants are encouraged to bring examples of Product Reviews as well as specific questions and concerns that can be discussed during this seminar.

Who Should Attend

This two-day seminar is targeted toward professionals who are responsible for the preparation of the FDA Annual Product Review, or Product Review, or the oversight of the preparation of the Product Review. This annual product quality review course also includes information that is pertinent to those who support process validation as defined in the FDA 2011 Process Validation Guidance and those who want to understand the potential impact of the FDA draft guidance on Quality Metrics on Product Reviews and the organization as a whole. This includes professionals in Quality Assurance, Quality Control, Production, Development and other related disciplines.

Course Agenda

First Day

Introductions

  • Participant introductions
  • Instructor introduction
  • Participant expectations

Regulatory Requirements for Product Reviews

  • Paragraphs of US, EU and Canadian GMPs and pertinent guidances that require a Product Review
  • Identify the specific expectations of each regulation.
  • The chronology of the issuance of the regulations and how that impacts the defined expectations
  • Expectations of management found in the regulations.
  • A preview of the impact of other guidances issued by the FDA

Impact of the Quality System

  • Introduce ICH Q10, the Pharmaceutical Quality System (PQS).
  • How each of the elements of the PQS impacts on the Product Review.
  • Other Quality Systems and what can be learned from them.
    • The QSR (21CFR820)
    • ISO 9000
    • ISO 13485
    • Baldridge

Product Review Content

  • Participant experiences
  • The specific requirements for the content of the Product Review found in regulations and guidances.
    • US GMP)
    • EU GMP
    • Canadian GMP
    • ICH Q7
    • GPG 7356.002
  • Comparison of expected content in the regulations
    • Common areas
    • Geographical impact
    • Impact of time

Recent Regulatory Activities

  • The FDA Process Validation Guidance and the FDA Quality Metrics Guidance.
  • How the Product Review can satisfy the FDA expectation for Continued Process Validation.
  • Risk management and the Product Review
  • How the reporting of Quality Metrics can be integrated into the Product Review process.

Review

  • Tie together all of the discussions of the day.
  • Answer questions. Note: the focus on answering questions will be at the end of the seminar

Second Day

The Expanded Role of the Product Review

  • How recent guidances have raised the visibility of the Product Review and management involvement.
  • The Product Review for multiple jurisdictions
  • The Product Review for a virtual organization

Product Review Content – revisited

  • The impact of recent guidances on the content or emphasis of the Product Review
  • New elements that should be included in the Product Review
  • New players in the preparation of the Product Review

Product Review Process

  • Identify where the information required for the Product Review is maintained.
  • Discuss the preparation of the Product Review.
    • Individual preparer
    • Preparation by multi-disciplinary team.
  • Discuss roles and responsibilities within the organization that relate to the preparation of the Product Review.
  • The Product Review for multiple jurisdictions
  • The Review for a Product manufactured in multiple facilities

Management Responsibilities

  • Review Management responsibility as discussed in the GMPs, ICH Q10 and the Quality Metrics Guidance.
  • How management responsibilities relate to the Product Review.
  • Identify the evolving expectation of the regulatory agencies as defined in recent guidances and demonstrated by recent regulatory observations.
  • Discuss specific expectations found in the Quality Metrics guidance.
  • Discuss the challenges to engaging management.

Product Review – an interactive discussion

  • Note: Throughout the seminar the participants will be encouraged to write questions that they think of on a piece of paper and place these questions in a designated location.
  • Discussion of questions.
  • Review of participant expectations.
  • Summary of the course

Quality System Review

  • Introduce the concept of the periodic review of the Quality System
  • How the periodic review of the Quality System is consistent with ICH Q10 and other contemporary Quality Systems
  • A system for the Quality System Review

Overview of Product Reviews

  • Tie together the Product Review and the Quality System Review
  • The future importance of the Product Review.
  • The Product Review and the Quality System Review as a tools for proactive continuous improvement.

Learning Objectives

By the end of this course, attendees will:

  • Understand the requirements for Annual Product Reviews.
  • Understand the impact of recent International and FDA actions and guidances on the Annual Product Review.
  • Understand the role of the Product Review in corrective actions, preventive actions and continuous improvement.
  • Be aware of systems that may be involved in the preparation of the product Review
  • Be aware of the role of management in an effective Product Review Program.
  • Be aware of potential future regulatory expectations that relate to the Product Review or Quality System Review.

Testimonials

"I enjoyed that the instructor did not spend time selling other courses or services! I found the handouts informative and liked hearing everyone’s issues and how they were resolved and the director’s suggestions." Maria S., QA Manager, Tec Laboratories
"The course was very well organized." Matthew K., Sr. Solution Consultant, Veeva Systems
"The Product Quality Review course was very informative and I appreciate all of the information in the workbook." Kim F., QA Manager, Tec Laboratories
"“The Course Director was very knowledgeable and the smaller class size made the interaction more enjoyable and more educational”" Maria S., QA Manager, Tec Laboratories