3-Hour Virtual Seminar on Process Validation for Drugs and Biologics

This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other systems such as Risk Management, Corrective and Preventive Action and Supplier Management.

Participants will learn how to develop rigorous protocols and reports, as well as create monitoring programs to ensure that defined critical parameters remain in control. The course will also review validation requirements for systems that generate electronic signatures and records as most new processes have this capability.

Course Objective:

Upon completing this course participants should:

  • Understand the new FDA perspective of a “Process Validation Life-Cycle” that starts at the Process Design phase (Process/Product Development) and continues through Process Qualification (Confirmation) and Continued Process Verification (Monitoring and Assessment of the process effectiveness) as stated by the FDA’s new Guideline on Process Validation and its impact on how process validation activities are carried out
  • Understand the perspective of the EMEA, ICH, WHO and PIC/S on process validation and how they can be incorporated into a single process validation system
  • Be able to set up process validation programs and corresponding documentation including protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
  • Prepare and defend your own process validation approach/program and avoid costly delays and rejections by regulatory agencies

FDB2484

Joy McElroy

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.

Session 1

 

I. Introduction to Process Validation

  • Regulatory Perspective – Biologics vs. Pharma
    • Defining Validation
    • Recognize the role process validation plays in understanding process and product variability – Making the Validation Fit Your Product
    • Types of Process Validation – Retrospective – Concurrent – Prospective
    • Understand the perspectives of the FDA, international regulators and the GHTF

II. Implementing a Process Validation System

  • Establishing the Infrastructure
    • The process validation procedure
    • Roles and responsibilities
    • Equipment and facilities
  • Process Validation Requirements
    • Requirements of Title 21
    • Review of the FDA Guidance on Process Validation
    • Differences between Regulatory Agencies Requirements
    • ICH
    • EMEA
    • PIC/S

Session 2

 

III. Executing a Validation

  • Other Related Components of Validation
    • Facility Validations
    • Cleaning Validations
    • Processing Equipment Validations
    • Viral Clearance Validation
    • Sterilization Validation
    • Packaging Validations
    • Computer System Validation

IV. Supplier Process Validations

  • Requirements of Suppliers
    • Validation based on supplier criticality
    • Role of Quality Agreement in Process Validation
    • Communication of process changes
    • Inspection vs Validation of supplied components

Session 3

 

V. The Validation Life Cycle

  • Re-validation
    • When, why and what
    • Handling problems during re-validation
    • Product and process implications
  • Product complaints and process failures
    • Evaluating process parameters as a cause of product failures
    • Process change history
    • Amending the existing MVP
  • Implementing the System
    • Assessing the status of existing systems
    • Identifying the systems to be validated
    • Determining when revalidation is required
    • Defining and controlling the Master Validation Plan (MVP)
    • An audit perspective of the MVP

VI. Process Validation Compliance

  • Avenues for Assessing Compliance
    • Internal audits
    • Complaints and corrective action
    • Process changes
    • Process FMEA
    • Review of recent Warning Letters and Consent Decrees

Attendance to this 3 hour webinar will be beneficial to personnel directly involved in process/product development, manufacturing, quality control/assurance and process validation. This includes both beginners and seasoned operational personnel who conduct process validations. Individuals in management who interact with previously mentioned staff or communicate with regulatory agency inspectors to rationalize or defend validation programs will also benefit from attending this course.

Participants should be familiar with FDA, ISO and EMEA requirements for process validation and have a good understanding of the Pharmaceutical and/or biologic Good Manufacturing Practices.

  • QA and QC managers
  • Quality Engineers
  • Validation managers
  • Validation Engineers and Specialist
  • Operations managers
  • Regulatory compliance managers and personnel

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance