Process Validation CONTENT Package

1. ONE HOUR - LIVE ONLINE RECORDING: FDA's NEW Process Validation Guidance: Primer on Actions You Need to Begin Taking NOW!

2. PowerPoint Training Presentation

3. Auditing Process Validation Checklist

4. Introduction to Validation and its Documentation (Reference Article) 

5. The Basics of Conducting Effective Validation: A GMP Training Session for New Employees  (Training Script)

6. Implementing IQ, OQ and PQ: Making Popcorn (Reference Article)

Process Validation CONTENT Package is only $99.00:

FDA Enforcement of Process Validation is increasing. Read below for recent Warning Letters excerpts

1.& 2. ONE HOUR - LIVE ONLINE RECORDING: FDA's NEW Process Validation Guidance: Primer on Actions You Need to Begin Taking NOW! And Powerpoint Training Presentation.

Instructor: Eldon Henson, Director API Products and R&D Quality, Covidien (formerly Mallinckrodt). He has 3,000+ hours of direct contact related to FDA investigations, most of which included coverage of process validation.

Live Online Recording Training Content:

• Background on FDA's New Guidance on Process Validation
• Why did FDA upgrade the Guidance on process validation now?
• Alignment with ICH Q8, Q9, and Q10
• Definition and goal of process validation
• Former approach compared to FDA's new approach
• Stage 1 - Process design
• Stage 2 - Process qualification
• Stage 3 - Continued process verification
• New Keys to a successful validation program
• Understand the sources of variation
• Detect the presence and degree of variation
• Understand the impact of variation on the process and product
• Control the variation commensurate with risk
• General considerations for process validation
• Stage 1 - Process Design: Key points and practical applications for:
  • Building and capturing process knowledge and understanding
  • Establishing a strategy for process control
• Stage 2 - Process Qualification: Key points and practical applications for:
  
  • Design of a facility and qualification of utilities and equipment
  • Process performance qualification (PPQ)
  • PPQ protocol
  • PPQ protocol execution and report
• Stage 3 - Continued Process Verification: Key points and practical applications for:
  
  • Concurrent Release of PPQ Batches
  • Documentation
  • Analytical Methodology
• What is FDA trying to accomplish and what benefits can be expected from this approach to process validation?
• What specific actions do we need to take now?
• Summary, conclusions, and final recommendations

3. Auditing Process Validation Checklist

57 Audit Checkboxes that include:

• Basic Elements of a Process Validation Program
• Validation Master Plan
• Process Validation Documentation
• Process Qualification Requirements
• Impact of Changes to Process Validation
• Revalidation

4. Introduction to Validation and its Documentation (Reference Article)
This article focuses on these key areas below in conducting effective validations, including:
➢ Validation and documentation
➢ GMP and validation requirements
➢ Key validation documents
➢ Equipment documentation
➢ Materials documentation
➢ Process and product documentation
➢ People documentation
Quiz provided
Numerous questions and answers testing is provided for training purposes

Bonus Attachments included: 
➢ Validation Master Plan
➢ Suggested content
➢ Format
➢ Validation Report
➢ Suggested content

5. Training Script: The Basics of Conducting Effective Validation: A GMP Training Session for New Employees
Critical principles of validation are illustrated in this simulated example of a consulting firm receiving a request from one of their clients who needs help developing a plan to validate one of their new packaging lines.

Subject matter content includes:
➢ FDA’s definition
➢ Validation documentation including:
➢ Master plan
➢ Protocol
➢ Reports
➢ IQ & OQ
➢ Equipment calibration
➢ Equipment maintenance and cleaning
➢ Supplier certification
➢ Materials
➢ Documentation which supports PQ
➢ Specifications
➢ Procedures
➢ Test methods
➢ Process parameters
➢ Change control
➢ …and more

Quiz provided
Numerous questions and answers testing reader’s comprehension are provided for training purposes

6. Implementing IQ, OQ and PQ: Making Popcorn (Reference Article)

Validation is a series of qualifications to demonstrate the suitability of equipment and control of the manufacturing process. The qualifications are Installation (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). This article reviews how IQ, OQ and PQ are implemented through using the example of making popcorn in a microwave oven.

• Quiz provided
• Numerous questions and answers testing reader’s comprehension are provided for training purposes.
• Essentials of writing an effective protocol are reviewed.
• A validation protocol worksheet is also included.

Process Validation CONTENT Package is only $99.00:

Recent Warning Letters excerpts: 
“There was no process validation study…”
Smith & Nephew 

“…you had not performed validation of the manufacturing process…”
Synbiotics
 
“…nor had you established a process design, a validation plan, or qualification protocols”
CP Pharmaceuticals

“Your firm failed to provide validation protocols that evaluated the impact of the increasing batch size on product quality…Further, your firm uses a “Master Validation Plan” for process validation on all products. Validation must be demonstrated for each product and process.”
Contract Pharmacal Corp.
 
“Failure to validate (product) to ensure that devices conform to defined user/patient needs and intended uses, as required by 21 C.F.R. § 820.30(g).”

“Failure to establish procedures and to validate a process whose results can not be fully verified by subsequent inspection and test, as required by 21 C.F.R. § 820.75(a).”
OsteoSymbionics 

“…your firm failed to perform process validation for three USP products: This is a repeat observation.  The June 2001 FDA inspection reported that your firm failed to conduct process validation studies for (product) a USP product manufactured at your facility. “

“Your firm failed to perform stability studies for (product) to support the (product) year expiration date currently assigned.  This is a repeat observation.  The June 2001 FDA inspection documented your failure to perform stability studies on (product), a USP product manufactured at your facility.”

“Your firm failed to perform cleaning validation studies to support the use of "city water" to clean all your equipment.”
Macco Organiques 

“Your firm has failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods [21 C.F.R. § 211. 165(e)].

For example, your firm performed analytical method transfers for 236 protocols without determining whether those methods had been properly validated by your clients.”
Advanced Testing Laboratory 

“…your firm has not conducted performance qualification for the unit-dose packaging machine to ensure its proper performance.”

Your “…response is inadequate in that it fails to adequately describe how and on which pieces of equipment qualification will be performed.”
Shamrock Medical Solutions Group 

“…you have not validated the manufacturing processes for the following drug products…”
Benev Company 

“…during the process qualification stage of the process validation for (product) you made equipment and process modifications without adequate change control.”
IriSys, Inc. 

“…we are concerned about the length of time your firm has needed to develop and implement its Validation Prioritization Plan …”
Hospira 

“We disagree with your assessment and we do not consider your process validated. Your investigation report conclusion was based on finished product test results alone, and did not consider in-process testing and analyses.”
Gilead Sciences

Process Validation CONTENT Package is only $99.00: