Dates: MAY 16 - 17, 2022

Time (Eastern Time US): 9 AM to 2 PM
Time (Central Europe): 3 PM to 8 PM

Duration: 2 DAYS

Course Director: JOY MCELROY

As Various parts of the world are still battling the Coronavirus (COVID-19), we are conducting the class 100% online.
PROCESS VALIDATION TRAINING COURSE (FDA AND EU ANNEX 15: QUALIFICATIONS aND VALIDATION)

RESERVE YOUR SEAT TODAY!

Joy McElroy

Joy McElroy offers 18 years of experience as a consultant and over 25 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. Ms. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.

This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.

This seminar will provide a channel to enhance understanding of the utilization of process validation and Phase 1, 2 and 3, where their guidance blend and where they remain distinct. In particular, Stage 3 continued process verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.

The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing.

Each facility, whether producing small or large molecules requires both an overall Site Validation Plan as well as specific validation plans to manage the multiplicity of validations required to confirm the successful manufacture of each of its products.

This two day, interactive Seminar which provides a conduit to enhance your understanding of the Continued Process Verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.

Common questions asked by the users of Process Validation include:
  • How does one integrate these two different concepts (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge?
  • Do they exist independently of each other or do they complement each other to enhance, build and provide a product that neither alone could. Questions that may arise include where are cGMPs initiated?
  • To what extent must they be used? Since Stage 3 extends through commercial batch manufacturing, what happens to Phase 3?
  • Does it follow along or with Stage 3?
  • These questions will be addressed within Stage 2 as presented here and include utilization of Process Validation and Phase 1, 2 and 3, where their Guidance blend and where they remain distinct. In particular, Stage 3.
  • Why these FDA Guidance/EU Guidelines for Industry – Process Validation is so important to the pharmaceutical and biotechnology industry.
  • What FDA segments are included and excluded within the “NEW” Process Validation.
  • Where does the Process Validation commence.
  • What are the Three Stages and Where They Apply within the NEW Process Validation.
  • How Stage 1 integrates with Phase 1.
  • The Validation approaches that are included within this Guidance document.
  • The Statutory and Regulatory Requirements for Process Validation.
  • An Introduction Phase 1 Guidance for Industry and Its Application within the “NEW” Process Validation.
  • The Phase 1 Investigational Drug Requirements – What is and What is NOT Required.
  • General Considerations for Process Validation – Stage 2 Process Qualification.
  • Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2.
  • General Considerations for Process Validation – Stage 3 Continued Process Verification.
  • A Review of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance.
Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Compliance Departments
  • Validation Teams
  • Product Development Teams
  • Project Management Teams
  • Engineering Departments
  • Manufacturing Departments
  • Contract Manufacturers
  • Internal Auditors
  • Facilities Professionals
09:00 AM - 02:00 PM
DAY 1

Lecture 1: Process Validation – Overview
- Introduction, Goals and Objectives, Definitions
- Its Importance within the Industry

Lecture 2: Phases and Stages
- Interaction of the Three Stages with Process Validation
- How the two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3)
- Where do they merge?
- Do they exist independently of each other?
- Do they complement each other to enhance, build and provide a product?

Lecture 3: Phase 1, 2 and 3
- Validation Approaches, cGMPs in Clinical Supply
- Manufacture, Special Manufacturing Situations within Phase 1
- The Requirements of Phase 1 Investigational Drug Requirements
- Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2

09:00 AM - 02:00 PM
Day 2

Lecture 4: Stages 2 and 3
- General Considerations for Process Validation – Stage 2 Process Qualifications
- Special Considerations for Process Validation – Stage 2
- General Considerations for Process Validation – Stage 3 Continued Process Verification

Lecture 5: EU Annex 15
- A Review of EU Annex 15
- Comparison to FDA’s Process Validation Guidance

Lecture 6: Process Performance Qualification (PPQ) Batches
- Concurrent Release of PPQ Batches
- Role of SOP in the company QM System
- How to deal with the established 3 batch approach?

Lecture 7: Analytical Methodology and Process Validation and Warning Letter examples

Sorry, registration has ended.

2-Day Virtual Seminar on Process Validation Training Course (FDA and EU Annex 15: Qualifications and Validation)

  • Date: 5/16/2022 09:00 AM
  • Location Online Event