Validation Training

Validation Training for Life Sciences & Pharmaceutical Industry Professionals

Personnel involved in qualification, validation & verification activities should be appropriately qualified, trained and experienced to fulfil their responsibilities. In this article, we’ll review online Qualification & Validation Training Courses including Certificate GMP courses from onlinegmptraining.com, and Pharmaceutical Manufacturing Fundamentals training, which is suitable for validation personnel, quality managers, pharmaceutical engineers, and cleanroom architects.

Training Requirements for Qualification & Validation Personnel

Qualification and validation activities are important aspects of quality assurance for medicinal products. Personnel responsible for validation activities, including cleaning validation experts and computerised system validation consultants, are expected to:

• Have completed formal qualification and validation training (GMP Compliance Training)
• Have adequate industry experience
• Have strong analytical capabilities
• Understand the importance of test method justification and validation
• Understand the product, production processes and equipment, and associated risks
• Understand the importance of ensuring data integrity

Some of the regulatory compliance knowledge required by Qualification & Validation Personnel can be gleaned (or enhanced) by completing online training courses. Popular validation training courses are a useful online training resource for GMP industry professionals and manufacturing consultants.

Note: One user per licence; 12 months access (24/7) and Certificate of Completion available after completing an online Course Assessment.

Importance of Qualification and Validation Training Courses

A key principle of Good Manufacturing Practice (GMP) is that personnel must be properly qualified and continuously trained according to their specific responsibilities and product risk assessments.

Validation Training Benefits for Pharmaceutical Engineers & Validation Consultants

Ongoing qualification and validation training helps validation personnel stay current with GMP compliance expectations and site inspection trends (audit findings), aiding their understanding of role responsibilities.

GMP Qualification and Validation Requirements

As a general concept, qualification and validation/verification activities help ensure facilities, utilities, equipment and processes:

• Are suitable for their intended purpose
• Function consistently as intended
• Meet requirements described in the User Requirements Specification (URS)
• Meet regulatory compliance responsibilities

FDA Definitions: Qualification & Validation vs Verification

Qualification generally means proving (via testing, calibrating, and other documented evidence) that premises, systems and equipment are properly installed and work correctly.

FDA definition of ‘validation’: “Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.”

FDA definition of ‘verification’: “Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.”

Source: United States Food & Drug Administration (US FDA), 21 CFR 820.3.

Qualification and validation training courses can help Manufacturers & Sponsors understand and comply with the following cGMP guidance:

• cGMP guidance published in EU Annex 15 and PIC/S Annex 15
• GMP Guide Parts I and II and other product-relevant Annexes
• FDA Guidance on Qualification and Validation
• TGA Guidance on Qualification and Validation
• The terms and conditions in their Marketing Authorisation(s) or Clinical Trial Authorisation(s)

Which validation training courses are recommended for GMP validation experts?

Qualification and validation personnel & consultants are expected to:

• Complete initial and ongoing qualification and validation training
• Have appropriate product knowledge and adequate industry experience

Why is ongoing validation training so important?

The complexity and critical nature of qualification and validation activities requires personnel to have a deep understanding of product risks, contamination prevention requirements, various processes, and regulatory requirements. Continuous training is crucial for these professionals to stay updated with the latest industry practices including their responsibilities to ensure the integrity of data as well as the quality, safety and efficacy of pharmaceutical products.

Equipment & Process Validation Guidance Publications

GMP expectations for qualification and validation are described in the PIC/S GMP Guides (Part I and Part II). Specific qualification & validation guidance is found in PIC/S Annex 15 (in line with EU Annex 15). Other resources include ISPE’s Good Practice Guide: Process Validation, FDA process validation guidance, cleaning validation guidance, & GxP computerised systems validation (as in PIC/S Annex 11 and the ISPE’s GAMP5 2nd Ed).

Why Continuous Training is Essential

1. Keeping Up with Regulatory Changes: The pharmaceutical industry and life sciences sectors are governed by a complex web of regulations that are constantly evolving. Regulatory bodies and industry groups (e.g., the US FDA, Australian TGA, EU EMA, UK MHRA, PIC/S, ISPE, etc.) regularly update their GMP, validation and data integrity guidelines to reflect new scientific knowledge and technological advancements. Continuous training ensures that validation professionals stay abreast of regulatory updates and implement them in their qualification and validation activities. Reminder: The Validation Master Plan (VMP) is subject to change control.
2. Enhancing Technical Skills: Validation processes involve sophisticated techniques and tools that require specialised knowledge and industry experience. Validation training options can provide validation experts with additional experience and practical knowledge of the latest technologies and methodologies used in the industry, as well as the latest guidance updates. This expertise is crucial for designing and executing effective validation protocols. Benefits include cost-saving efficiencies and the prevention of deviations and recalls.
3. Ensuring Consistency & Compliance: Consistency in manufacturing and cleaning processes is vital for product quality and patient safety. Validation training helps GMP professionals better understand the principles of process control and standardisation, enabling them to develop and implement robust validation protocols (and data collection systems) that ensure consistent and compliant outcomes as well as data integrity compliance.
4. Improving Problem-Solving Abilities: Validation professionals often encounter complex challenges that require innovative solutions. Training programs can help enhance problem-solving skills by exposing validation professionals to additional scenarios and real-world validation case studies. Such exposure can equip validation personnel and quality managers/cleanroom engineers with the tools and techniques they need to address validation issues effectively.
5. Fostering Professional Growth: Continuous training is an investment in the professional development of validation professionals and aids personnel retention efforts. By providing your quality management personnel and validation professionals with opportunities to expand their knowledge and advance their careers, you empower them to contribute more effectively to your organisation. Well-trained professionals are also more likely to be recognised for their expertise and leadership throughout the sector. This improves your company’s reputation as well as the team member’s professional reputation in the life sciences industry (a mutually beneficial investment and reward). Well-trained validation personnel will also be better equipped to assist with improvement initiatives and to respond to GMP compliance inspections.

Key Training Courses for Validation Professionals

To meet the diverse training needs of validation professionals, onlinegmpraining.com offers a range of specialised courses in GMP and GxP compliance.

These GMP eLearning courses are suitable for a global audience, helping to reinforce your company’s GMP compliance culture while advancing your professional career.

Here are several essential GMP courses highly recommended for Validation professionals, Quality Managers, pharmaceutical engineers, and cleanroom architects.

1. Pharmaceutical Manufacturing Fundamentals (PMF Series)

This course provides a comprehensive overview of the fundamental principles and practices of pharmaceutical manufacturing. It covers critical pharmaceutical manufacturing topics such as contamination prevention, product containment, HVAC systems and pharmaceutical water systems. Participants gain a deep understanding of the entire manufacturing process.

Key topics in this GMP eLearning course include:

• GMP requirements and cleanroom engineering basics for pharmaceutical manufacturing.
• The importance of maintaining control over manufacturing processes including contamination prevention, product containment, and pharmaceutical water quality.
• Insights into quality management systems and their role in ensuring product quality and compliance.

Click here for this 4-part Certificate Training Course (Pharmaceutical Manufacturing Fundamentals).

You can also purchase these courses individually.

2. Annex 15 – Qualification & Validation

Annex 15 of the EU GMP guidelines provides comprehensive guidance on the validation and qualification of pharmaceutical manufacturing processes, equipment, and facilities. This course offers an in-depth understanding of the requirements and recommendations outlined in Annex 15, helping validation professionals ensure compliance with European regulatory standards.

Key topics in this GMP eLearning course include:

• The scope and application of Annex 15.
• Requirements for process validation, including prospective, concurrent, and retrospective validation.
• Qualification of equipment, utilities, and facilities.
• Ongoing process verification and maintaining a state of control.

Participants will gain practical insights into implementing Annex 15 guidelines in their organizations, ensuring that validation processes are thorough, consistent, and compliant with PIC/S Annex 15/EU Annex 15.

Click here for the Certificate GMP Course covering PIC/S Annex 15 Qualification & Validation (Online GMP Compliance Training).

3. Cleaning Validation

Cleaning validation is a critical aspect of GMP compliance, ensuring that manufacturing equipment and facilities are free from contaminants, carryover residues or cleaning product chemicals that could compromise product quality. While Annex 15 includes some elements of cleaning validation, there is also a specific cleaning validation course for cleaning validation experts.

Key topics in this GMP eLearning course include:

• The principles and objectives of cleaning validation.
• Cleaning validation protocol examples and acceptance criteria.
• Techniques for sampling and testing to verify the effectiveness of cleaning procedures.
• Regulatory requirements and best practices for cleaning validation.

By completing this course, validation professionals will be equipped with the knowledge and skills needed to ensure that cleaning processes are validated and compliant with regulatory standards.

Click here for the Cleaning Validation Certificate Training Course (online GMP training).

4. Annex 11 and GxP Computerised Systems Validation

The validation of computerised systems and other automated processes is crucial for ensuring product quality and patient safety.

Two courses relevant to GxP computerised systems and computer system validation activities include PIC/S Annex 11 and GxP Computerised Systems validation compliance training.

Key topics in these GMP eLearning courses include:

• GMP guidelines for computerised systems
• The principles and objectives of computer system validation.
• Regulatory requirements and best practices for validation activities.
• Understanding PIC/S GMP, GAMP5 (2nd Edition) and GxP guidance and validation responsibilities.

Click here for GxP Computerised Systems Validation Training

Click here for PIC/S Annex 11 – Computerised Systems (GMP requirements)

Conclusion

Ongoing qualification and validation training is a GMP requirement for validation personnel and validation consultants working in the highly regulated pharmaceutical manufacturing and life science sectors. Continuous training is essential for these professionals to stay current with industry advancements, regulatory changes, and best practices.

By investing in online GMP training courses such as Pharmaceutical Manufacturing Essentials, Cleaning Validation, PIC/S Annex 15 and GxP Computerised Systems validation courses, validation professionals can enhance their skills, improve their regulatory compliance knowledge and problem-solving abilities, and contribute more effectively to their organisations.

In an industry where the stakes are high (patient safety, product safety) and the regulatory landscape is constantly evolving, the importance of continuous training for validation professionals cannot be overstated.

As it is in all life science and pharmaceutical industry professions, ongoing training is a key driver of excellence, data integrity, and regulatory compliance for validation professionals & other quality assurance personnel.

With affordable GMP eLearning options including qualification and validation training, you can reinforce and expand your GMP compliance knowledge and enhance the capacity of your manufacturing and quality assurance teams. Browse over 70 GMP eLearning courses.