Process Validation for Drugs and Biologics

1. GRC Training Solutions

2. Description: • This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other systems such as Risk Management, Corrective and Preventive Action and Supplier Management.Participants will learn how to develop rigorous protocols and reports, as well as create monitoring programs to ensure that defined critical parameters remain in control. The course will also review validation requirements for systems that generate electronic signatures and records as most new processes have this capability.

3. Course Objective: • Upon completing this course participants should:• Understand the new FDA perspective of a "Process Validation Life-Cycle" that starts at the Process Design phase (Process/Product Development) and continues through Process Qualification (Confirmation) and Continued Process Verification (Monitoring and Assessment of the process effectiveness) as stated by the FDA's new Guideline on Process Validation and its impact on how process validation activities are carried out•    Understand the perspective of the EMEA, ICH, WHO and PIC/S on process validation and how they can be incorporated into a single process validation system•    Be able to set up process validation programs and corresponding documentation including protocols and reports that meet current FDA, WHO, PIC/S and EU regulations•    Prepare and defend your own process validation approach/program and avoid costly delays and rejections by regulatory agencies

4. Course Outline: • Introduction to Process Validation •    Regulatory Perspective – Biologics vs. Pharmao    Defining Validationo    Recognize the role process validation plays in understanding process and product variability – Making the Validation Fit Your Producto    Types of Process Validation – Retrospective – Concurrent - Prospectiveo    Understand the perspectives of the FDA, international regulators and the GHTF

5. II. Implementing a Process Validation System •    Establishing the Infrastructureo    The process validation procedureo    Roles and responsibilitieso    Equipment and facilities•    Process Validation Requirementso    Requirements of Title 21o    Review of the FDA Guidance on Process Validationo    Differences between Regulatory Agencies Requirements1 ICH2 EMEA3 PIC/S

6. III. Executing a Validation •    Other Related Components of Validationo    Facility Validationso    Cleaning Validationso    Processing Equipment Validationso    Viral Clearance Validationo    Sterilization Validationo    Packaging Validationso    Computer System Validation

7. IV. Supplier Process Validations •    Requirements of Supplierso    Validation based on supplier criticalityo    Role of Quality Agreement in Process Validationo    Communication of process changeso    Inspection vs Validation of supplied components

8. V. The Validation Life Cycle •    Re-validationo    When, why and whato    Handling problems during re-validationo    Product and process implications•    Product complaints and process failureso    Evaluating process parameters as a cause of product failureso    Process change historyo    Amending the existing MVP •    Implementing the Systemo    Assessing the status of existing systemso    Identifying the systems to be validatedo    Determining when revalidation is requiredo    Defining and controlling the Master Validation Plan (MVP)o    An audit perspective of the MVP

9. VI. Process Validation Compliance •    Avenues for Assessing Complianceo    Internal auditso    Complaints and corrective actiono    Process changeso    Process FMEAo    Review of recent Warning Letters and Consent Decrees

10. Target Audience: • Attendance to this 3 hour webinar will be beneficial to personnel directly involved in process/product development, manufacturing, quality control/assurance and process validation. This includes both beginners and seasoned operational personnel who conduct process validations. Individuals in management who interact with previously mentioned staff or communicate with regulatory agency inspectors to rationalize or defend validation programs will also benefit from attending this course.Participants should be familiar with FDA, ISO and EMEA requirements for process validation and have a good understanding of the Pharmaceutical and/or biologic Good Manufacturing Practices.•    QA and QC managers•    Quality Engineers•    Validation managers•    Validation Engineers and Specialist•    Operations managers•    Regulatory compliance managers and personnel

11. Instructor Profile: • Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing.  Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.  Now with 12 years experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.Joy specializes in Equipment Qualification, Cleaning Validation, Sterilization, Environmental Monitoring, and GMP Compliance Auditing.

12. Available Options: Live : For one participant $179 Corporate Offer 1 : Max 3 - 5 Participants $499 Corporate Offer 2: Max 10 Participants  $699 Recorded Webinar: Get unlimited access to the link for six months $ 229 Get CD/DVD: $339 Super Combo Offer 1: For One partcipant Live and Recorded webinar Only! $389