FREE TALK | Process Validation for NPI Projects – Defect Prevention and Reliability Assurance

Registration:

Choy-Yen Liew (a.k.a “CY”)

• Chemistry & Management, Lead Auditor ISO9001 & 13485, Auditor SA8000, GB & BB, Lean Practitioner, HRD Corp Accredited Trainer

All are welcome. Please help to share with your friends and colleagues too. 

Program Synopsis:

Process Validation (PV) is a critical quality assurance activity that ensures a process consistently produces a product that meets predefined specifications and quality attributes. It’s important in manufacturing to ensure reliability, safety, and efficiency of the produced products. The concept revolves around confirming that a process is capable of consistently producing a desired outcome under the conditions it is expected to operate.

Process Validation is critically important in manufacturing before commencing commercial production for below key reasons. It ensures

• Product Quality and Consistency
• Regulatory Compliance
• Risk Mitigation
• Cost Efficiency
• Supports Continuous Improvement
• Documentation and Traceability

Several organizations, quality management standards, legislation, and regulatory bodies have specific requirements regarding Process Validation in manufacturing environments. These guidelines and regulations ensure that manufacturing processes are capable of producing products that meet quality and safety standards. An overview of the key entities and their requirements are as follows:

• ISO 9001, ISO 13485: General and medical device standards requiring process validation.
• USP Chapter <1058>: Pharmaceutical process validation.
• 21 CFR Parts 211 and 820: U.S. regulations for pharmaceuticals and medical devices.
• EU Directive 2001/83/EC: European pharmaceutical regulations.
• FDA, EMA, Health Canada, WHO: Regulatory bodies providing guidelines for process validation.

• FDA FSMA, Regulation (EC) No 852/2004, ISO 22000:2018: Food businesses implement HACCP principles, including the validation of CCPs and control measures.

After the process is validated, maintaining control and ensuring ongoing compliance are crucial, especially if there are changes in production equipment, materials, or procedures. Therefore, Continuous Monitoring, Change Control and Periodic Revalidation should be the key components in Process Validation Plan.

 This 1.5-hour forum aims to provide an overview on regulatory and QMS requirements regarding Process Validation, key components of Process Validation and maintenance of state of validation.

Program Content:

1. Regulatory & Quality Management System (QMS) Compliance
2. Introduction To Process Validation
3. Components Of Process Validation
4. Maintaining State Of Validation

Tentative Program Flow:

8:15 pm – 8:30 pm: Regulatory & Quality Management System (QMS) Compliance

8:30 pm – 8:50 pm: Introduction To Process Validation

8:50 pm – 9:10 pm: Components Of Process Validation

9:10 pm – 9:30 pm: Maintaining State Of Validation

9:30 pm – 9:45 pm: Q&A

Speaker Profile:

Choy-Yen Liew (a.k.a “CY”)

• Chemistry & Management, Lead Auditor ISO9001 & 13485, Auditor SA8000, GB & BB, Lean Practitioner, HRD Corp Accredited Trainer

CY is a seasoned professional with a BSc. in Chemistry and Management from University Science Malaysia, bringing over three decades of expertise to the table. Throughout her career, she has held pivotal roles spanning Quality & Reliability Engineer, Laboratory Manager, Senior QA & Regulatory Manager, and Quality Director in multinational corporations. CY’s qualifications include certifications as a Lead Auditor for ISO9001 and ISO13485, as well as proficiency in Lean & Six Sigma methodologies. She excels in setting organizational quality goals and spearheading improvement roadmaps. She has demonstrated her leadership prowess by guiding factory functional heads of various global manufacturing locations, ensuring alignment and achievement of strategic objectives. Beyond her technical acumen, CY’s passion lies in mentoring/coaching and developing emerging leaders within organizations, underscoring her commitment to fostering talent and driving long-term success.

Program Logistics:

Date:  26 August 2024 (Monday)

Time: 8:30 pm – 10:00 pm

Venue: Live Online via ZOOM

For further clarification kindly contact: [email protected]

 Joining link will be emailed to REGISTERED PARTICIPANT a day before the session.