PDA Parenteral Learning Week

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Program Highlights

Led by our global experts, PDA Parenteral Learning Week will cover:

  • The latest innovations in pharmaceutical manufacturing
  • Improving knowledge transfer
  • Supply chain efficiencies
  • Modernizing process validation
  • Regulatory approach and challenges
  • Process Simulation for Aseptically Filled Products (Training)

 

PDA Asia-Pacific is proud to bring to you our LEARNING WEEK Series. The first of the series, PDA Parenteral Learning Week, is a content-rich program that will gather our industry's best talents to share the most current Parenteral information.

The first three days will have an overarching theme that is broken down into five specific topic sessions. The fourth and final day will be a training session on PDA 374.1 Technical Report No. 22: Process Simulation for Aseptically Filled Products.

You have the flexibility to choose between a short 2.5 to 3 hour session, or the spread of the entire four days. Most importantly these pre-recorded sessions are affordable and of great value.

More information coming soon.

Day 1

MOVING AT THE SPEED OF SCIENCE: PFIZER-BIONTECH COVID-19 VACCINE
JOHN F. KELLY
BREAK
DEPLOYMENT OF NEW TECHNOLOGIES IN REAL WORLD BIOPHARMACEUTICAL MANUFACTURING
JEFFREY C. BAKER
ASEPTIC PROCESSING - LOOKING TOWARDS THE FUTURE
EMILY CHEAH (MODERATOR)
ASEPTIC PARAMETRIC RELEASE
FREDERIC AYERS
BREAK
CAMPAIGN PROMISE: POINTS TO CONSIDER WHEN DESIGNING A MULTI-BATCH ASEPTIC PROCESSING CAMPAIGN
STEPHEN E. LANGILLE
BREAK
A REVIEW OF INNOVATIVE FACILITY OPTIONS IN AN ERA OF URGENT CAPACITY NEEDS
PETER J. MAKOWENSKYJ
BREAK
QUALIFICATION OF X-RAY STERILIZATION FOR SINGLE-USE BIOPROCESS EQUIPMENT
JAMES J. HATHCOCK
BREAK
BLOW FILL SEAL TECHNOLOGY IS EXPANDING ITS REACH INTO THE ASEPTIC PROCESSING WORLD
LEONARD F. PAUZER

Day 2

IMPROVING, MODERNIZING, TRANSFORMING
BRUCE LOXLEY (MODERATOR)
AUTOMATED CPV REPORTING: FROM ROUTINE COMPLIANCE EXERCISE TO STATE-OF-THE-ART PROCESS MONITORING
ASHWIN MONIAN
BREAK
RISK-BASED CLEANING VALIDATION • MATHEMATICS OF MAXIMUM SAFE CARRY OVER • DEVELOP AND APPLY LIMITS
JAVIER CARDENAS, SUSAN B. CLEARLY
BREAK
THE USE AND MISUSE OF ASEPTIC PROCESS SIMULATIONS IN THE VALIDATION OF THE ASEPTIC PROCESSES
HAL BASEMAN
BREAK
NOVO NORDISK APPROACH TO MODERNIZING EXISTING FACILITIES BY INTRODUCING NEW INNOVATIVE TECHNOLOGIES AND PROCESSES
THOMAS BUSCH
BREAK
PRE-USE/POST STERILIZATION INTEGRITY TESTING • RESULTS OF THE SFQRM
MAIK JORNITZ

Day 3

QRM AND KNOWLEDGE MANAGEMENT
LESSONS LEARNED FROM QRM PRACTITIONERS
TIFFANY BAKER, AMANDA M. MCFARLAND, DANICA BROWN
BREAK
RISK MITIGATION THROUGH PHYSICAL AND CHEMICAL TESTING: LYOPHILIZED DRUG PRODUCT CASE STUDY
DIEGO A. ZURBRIGGEN, SAMANTHA SINGER
BREAK
CAPTURING AND MONITORING PRODUCT DEVELOPMENT KNOWLEDGE
RHONDA SUNDBERG
BREAK
HOLDING ON TO WHAT YOU KNOW: IMPROVING KNOWLEDGE TRANSFER TO REDUCE RISK AND BENEFIT PATIENTS
MARTIN J. LIPA
BREAK
ORGANIZATION, GOVERNANCE AND COMPETENCY DEVELOPMENT FOR SUCCESSFUL PARENTERAL MANUFACTURING
MAURO GUSTI

Day 4

PDA 374.1 TECHNICAL REPORT NO. 22: PROCESS SIMULATION FOR ASEPTICALLY FILLED PRODUCTS
HAL BASEMAN

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.