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
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
Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.
Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.
In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off – site training to pharmaceutical and biotech companies throughout the United States.
Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.
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