Process Performance Qualification, Serialization and CPV Workshop

Including: Risk Analysis, Alternative API, Excipients, and Packaging

Register online | Download Registration Form (PDF)

Dates Available

May 3, 2019

Time

9:00 a.m. – 5:00 p.m.

Cost

CAD $685.00 + HST

Location

AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

Distinguished Faculty

Mr. Eran Oz

Director, Technical Operations
APOTEX

After completing and graduating with his Biotechnology Engineering degree (B.Sc.Eng) from Ben Gurion University, Israel, Eran began his pharmaceutical career at a startup company as a researcher.

In 2003, Eran joined TEVA Pharmaceutical , Israel, as a Project Development Manager in the R&D division and was both directly and indirectly responsible for the development, executions , validations and launches of dozens of solids, semi-solids, nasal sprays , otic and ophthalmic products to the US, EU, CA and local market, as well as site transfers within TEVA sites across the world.

In 2007, Eran completed and graduated with his Master Degree in Industrial Engineering and Management (M.Sc.Eng). He was relocated to TEVA Canada, and held several progressive management positions since in the Technical Operations group, where he was mainly responsible for the executions of Process Validation activities related to TEVA Canada solid dose products.

In January 2014, Eran joined the Apotex Pharmaceuticals Group in the capacity of Director, Global Technical Operations for all OSD sites.

Abstract

In 2011 ,the FDA published its most current and updated view of what is considered to be one of the most important foundations of the pharmaceutical industry, Process Performance Qualification (PPQ), formerly known as Process Validation.

Many seminars, courses and presentations have been trying to propose interpertations, assess risks and propose a path forward.

This workshop will encompass NOT ONLY the PPQ (Stage 2) and CPV (stage 3)aspects and the FDA most recent guideline in terms of analysis, policy proposals and interpertations, but also:

  1. Capture the risk analysis involved with the installation,qualification and validation of the equipment used for manufacturing of Finished Products(FP):
    1. The role of proper design, installation and qualification of major equipment and the fine tuning required for a successful , robust, continued operation towards product robustness.
    2. The equivalency between identical pieces of equipment as a key to a successful commercial runability of a product.
  2. Capture the risk analysis involved with the development, qualification and validation of the FP:
    1. What is the criteria for a higher risk manufacturing and how can it be determined in order to minimized and perhaps avoide the risk.
  3. The proper assessments of Alternative APIs and excipients in terms of analysis, criteria, justification and cost involved:
    1. Under the heavy regulated environment, increase in cost is a given which puts the pharmaceutical industry under pressure. Further more , the competitive environment forces us to seek for cost savings which can be addressed partially by Alternative APIs and excipients incorporated into our products.
    2. Are we obliged to follow the full PPQ route in these cases or there is an alternative? If there is a proposed alternative, what is the justification and how do we satisfy regulatory agencies?
  4. Hold time studies – Bulk, FP and intermidiate solutions:
    1. As per recent broad trend of Regulatory agencies to enforce Hold Time Studies for major steps in the manufacturing process, the various stages will be discussed as well as the justifications, rational and cost involved.
  5. Sampling plans – justifications and cost:
    1. Do we need extra sampling incorporated into our studies? Ahead of the validation? Perhaps we can eliminate sampling. We will discuss FDA guideline for proposed sampling that can potentially help reducing the cost of sampling as well as time taken from the production floor.
  6. Packaging Validation
    1. This subject will be discussed as part of the FP on-going monitoring.
  7. Statistical analysis – tools proposed as well as parameters:
    1. With Stage 3 from the FDA Guideline coming into play, the need for an efficient statistical tool not only for analysis but also on-going (online?) monitoring of commercial lots will be discussed and proposed.
  8. Propose and justify a path forward

In this one day workshop, study cases will be presented and discussed for each section of the above in details, based on the speaker’s hands-on vast experience and knowledge within the industry and will be tied into the theoretical proposed policies and guidelines.

The goal and hope is that at the end of this one day workshop, the attendees will have aquired the tools and knowledge to be able to propose, justify and implement path forward that is acceptable by regulatory agencies in their areas of experties.

Who Should Attend

QA, Validation, Compliance, Technical Services, Technical Operations, Process Development and Procurment for the API section

Course Material

  • The participants will be receiving specially prepared course manual.

Note: Registration closes one week prior to the start of workshop.