This training course provides an understanding of process validation requirements for pharmaceutical and biologic products. Participants will learn how to establish effective process validation systems and integrate them with other quality systems. They will also learn how to develop validation protocols and reports, as well as monitoring programs, to ensure critical process parameters remain in control. The course reviews validation needs for electronic systems and covers the FDA's process validation lifecycle approach.

1. GRC Training Solutions

2. Description:
• 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.

3. 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

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

5. II. Implementing a Process Validation System
• Establishing the Infrastructure
o The process validation procedure
o Roles and responsibilities
o Equipment and facilities
• Process Validation Requirements
o Requirements of Title 21
o Review of the FDA Guidance on Process Validation
o Differences between Regulatory Agencies Requirements
1 ICH
2 EMEA
3 PIC/S

6. III. Executing a Validation
• Other Related Components of Validation
o Facility Validations
o Cleaning Validations
o Processing Equipment Validations
o Viral Clearance Validation
o Sterilization Validation
o Packaging Validations
o Computer System Validation

7. IV. Supplier Process Validations
• Requirements of Suppliers
o Validation based on supplier criticality
o Role of Quality Agreement in Process Validation
o Communication of process changes
o Inspection vs Validation of supplied components

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

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

10. Target Audience:
• 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

11. Instructor Profile:
• Upon earning a degree in Zoology at North Carolina State University, Joy
made her debut in the pharmaceutical industry in 1992 at Pharmacia &
UpJohn performing Environmental Monitoring and Sterility Testing. Her
hard work allowed her to move into a supervisory role at Abbott
Laboratories where she oversaw their Quality Control Lab.
Now with 12 years experience as a consultant, and over 20 years total
experience in the pharmaceutical and biotech industries, Joy has gained
extensive knowledge of Quality Assurance, Process and Cleaning
Validation, and Equipment Qualification. She has written and executed
Equipment Qualification and Validation Protocols for numerous Companies
such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips
Medisize, Xcelience, and Novartis.
Joy specializes in Equipment Qualification, Cleaning Validation,
Sterilization, Environmental Monitoring, and GMP Compliance Auditing.

12. Available Options:
Live : For one participant
$179
Corporate Offer 1 : Max 3 - 5 Participants
$499
Corporate Offer 2: Max 10 Participants
$699
Recorded Webinar: Get unlimited access to the link for six months
$ 229
Get CD/DVD:
$339
Super Combo Offer 1: For One partcipant Live and Recorded
webinar Only!
$389