Process Validation: A Lifecycle Approach — Oral Solid Dosage/ Semisolid Dosage Forms Annex - New Course

Bethesda, MD
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

The participant will learn how to employ process understanding and quality risk management principles to the three Process Validation concepts described below:

  • Stage 1: Process Design
  • Stage 2: Process Qualification
  • Stage 3: Continued (Ongoing) Process Verification (CPV)

In addition, the participant will learn how to apply Stage 3 CPV concepts to existing company/site legacy products.

Who Should Attend

Managers, directors and new or experienced professionals in process development, process validation, and quality assurance personnel will benefit in taking this course.

More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Describe the requirements for the development of of a new product using a Process Design Stage and apply the lessons learned to your workplace
  • Explain the requirements for the development of a new product using a Process Qualification Stage and apply the lessons learned to your workplace
  • Demonstrate the ability to respond to unexplained departures from established ranges with clear identification of impact including linkage to the firm’s quality systems
  • Develop a Stage 3 Continuous Process Validation program for legacy products which includes linkage to the firm’s quality systems
Agenda is subject to change.

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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD , United States

José L. Toro, PhD, Principal Consultant, Lachman Consultants

José L. Toro, Ph.D. is a Principal Consultant in the Compliance Practice at Lachman Consultants who has extensive R&D Quality, and Quality Operations experience in the pharmaceutical industry. Dr. Toro specializes in the transformation of Quality and Technical Services organizations including Quality Systems, global implementations, corporate auditing, technology transfer and plant operations. He has a broad knowledge of regulatory compliance and quality control. Dr. Toro is well versed in FDA, MHRA, IMB, ANVISA; Japan and Korean inspections. He is highly experienced in manufacturing technologies for most dosage forms (aseptic processing, complex prefilled syringes, extended-release solids, liquids, semi-solids) parenterals, medical devices, combination products, as well as bulk operations. Dr. Toro co-authored the PDA Technical Report (TR 60-2) on Solid and Semi-solid Process Validation.