Body of Knowledge for Validation Certifications

The Body of Knowledge consists of the topics that will be discussed in the Validation Certifications Courses. The Body of Knowledge is presented using the following format:

1) Basic Validation Concepts and Documentation  
Presents the basic principles and organization for conducting effective qualification/validation studies for the pharmaceutical and medical devices industries. Some of the topics to be covered are:

• Organizing for validation 
• Validation Program 
  • Life Cycle 
  • Phases 
• Documentation 
  • Policies 
  • Standards 
  • Validation Manual 
  • Master Plans 
  • SOPS 
  • Change Control 
  • Technology Transfer Document 
  • Specifications 
  • Protocols and Reports 
• Revalidation 
• Personnel Certification 
• References 

Instructor: Magaly Vega PhD, RPh 
Days: 2

2) Qualification Studies: Facilities, Utilities & Equipment

Delineate the elements of facilities, utilities and equipment qualification activities. Some of the topics to be covered are:

• Regulations
• Design Qualification
  • Requirements
  • Documentation
• Commissioning
  • Activities
  • Documentation
• Documents
  • IQ protocol
  • OQ protocol
  • PQ protocol
• Facilities Qualification: IQ, OQ, PQ
• Utilities Qualification
  • Water system
  • Compressed air system
  • Nitrogen
  • HVAC system
  • Clean steam system
• Equipment Qualification
• Periodic Review
• Performance monitoring
• Retirement

Instructor: Magaly Vega PhD, RPh 
Days: 2 

3) Regulatory Trends

Present the basic concepts of regulatory compliance regulations, industry trends and the responsibility of validation professionals to ensure they comply with these standards and regulations:

1. Present the most relevant regulations and guidelines governing the pharmaceutical industry. 
2. Define the four compliance requirements of a drug. 
3. Describe the Drug Approval Process for a US drug. 
4. Understand the history of the FDA and the basis of their requirements. 
5. Present the different agencies that regulate the healthcare industry. 
6. Explain the type of deficiencies that drive a regulatory agency to take enforcement actions.
7. Present that Quality Systems that the healthcare industry must have in place. 
8. Present the Validation Control Systems that the industry must have in place to ensure validated status is not jeopardized.
9. Present the Quality Assurance Pyramid 
10. Discuss case studies of regulatory enforcement actions in the industry 

Instructor: TBD
Days: 1

4) Supplier Certification

• FDA Requirements
• What do you expect from suppliers?
• Supplier Certification Team and Responsibilities
• Supplier Selection Criteria and Process
• APQP Process
• Supplier De-certification, Criteria and Re-certification
• Quality Audit Definition
• Audit Planning and Implementation
• Supplier Control Plan
• Supplier Annual Validation
• Supplier Performance Measurement
• Supplier Scorecard
• Design and Development Capabilities

Instructor: Heriberto Lorenzo, BSIE
Days: 1

5) Risk Management
New FDA initiative. Some of the topics to be covered are: 

• Prerequisites to HACCP Program 
• Seven Principles HACCP 
• Developing a HACCP Plan 
• Application of HACCP Methodology in Pharmaceutical and Medical Devices 
• Risk Analysis and HACCP 
• Risk Analysis Techniques (DMAIC) 
• ISO 13485 Medical Devices—Quality Management (Risk Based)  

Instructor: Carlos Urrutia, BSME, C-HACCP & SSGB 
Days: 2

6) Cleaning Validation
Presents the basic principles and organization for effective validation of cleaning procedures. Some of the topics to be covered are: 

• FDA requirements in cleaning validation 
• Documentation requirements for cleaning validation (pre-validation studies) 
• Planning and strategies 
• Setting limits 
• Cleaning validation sampling techniques and locations 
• Surface area calculations 
• Critical points selection 
• Equipment holding 
• Validation Maintenance 

Instructor: Vilmary Negrón , BSChE, MSChE
Days: 1 

7) Statistical and Validation Matrix Approach Topics
Some of the topics to be covered are: 

1. Validation Supported by Six Sigma 
   1. Statistic /Quality Tools / Interpretation 
   2. Process Characterization / Capability 
      - How to Establish Baseline Criteria / Risk Analysis 
      - Identify Sources / Causes of Variability / Assess Process Capability 
      - Establish Operation Range (Design of Experiment) 
      - Establish Control Measures 
   3. Benefits 
2. Process Performance Qualification / Process Validation Matrixing and Bracketing Approach 
   1. Definition and Scope 
   2. Evaluation of Process / Products / Equipment Similarities 
   3. Establishing a Scientific Rationale for Number of Replicate Runs / Batches 
      - How to Documents Rationale and Where 
   4. Limitations / When Should Be Used 
   5. Case Studies: Covering Solid Dosage Form and Aseptic Manufacturing / Packaging 

Instructor: Vilmary Negrón , BSChE, MSChE  
Days: 1 
 
 

Specialized Modules 

1) Computer Systems Qualification & Validation
Presents the basic principles and organization for effective validation of computerized systems. Some of the topics to be covered are:

• Principles & regulations
• System development, life cycle approach
• Specification, design and vendor assessment guidelines
• Documentation requirements
  1. Developing quality user requirements specification
  2. Writing quality test scripts
• Computer Installation Qualification & software validation
  1. Effective system testing
  2. Computer validation for open systems
  3. Validating legacy systems 
• 21 CFR Part 11
• Change & security management guidelines
• Computer operational and performance qualification
• Introduction to risk based computer system validation

Instructor: José Correa, PE, MBA 
Days: 3

2) Pharm Tech I: Parenterals (Processes & Packaging)
This course presents the basic principles and controls for the manufacturing processes and equipment for the manufacturing of parenteral dosage forms. Some of the topics to be covered are: 

• FDA Sterile Processes regulatory perspectives 
• Facilities and Utilities 
• Environmental Controls 
• Sterilization Processes 
• Lyophilization Process 
• Aseptic Techniques 

Instructor: TBD 
Days: 2 

3) Pharm Tech II: Solids (Processes & Packaging)
Delineate the elements of process validation activities. Some of the topics to be covered are: 

• Guidelines for process validation 
• Preliminary considerations 
  1. Pre-validation & development phases 
  2. Process Capability 
• Raw material validation 
• Process Validation Options 
  1. Prospective
  2. Retrospective
  3. Concurrent
• Critical process parameters and outputs
• Validation strategies: experimental design and sampling
• Test cases
• Documentation
• Holding times studies
• Revalidation

Instructor: Magaly Vega , PhD, RPh 
Days: 2

4) Medical Devices

• Principles of Validation 
• Validation Master Plan / Program 
• Decision Tree / Realization Program
• Validation Approach 
• Validation Stages: DQ, RA. IQ, OQ & PQ 
• Packaging Review Base on ISO/ANSI/AAMI 11607 & EN 868 
  1. (PETG Thermoform Tray/Tyvek Lid & Pouch) 
  2. Packaging Type 
  3. Packaging Process 
• Micro-Biology and Sterilization Review for Validation 

Instructor: Carlos Urrutia, BSME, C-HACCP & SSGB Days: 2 

5) Biotechnology

Instructor: TBD  
Days: 2

6) Validation of Analytical Methods

Instructor: TBD 
Days: 2