Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry.
Shawn Gould is Director of Compliance with Johnson & Johnson’s Regulatory Compliance group. He currently holds responsibilities in the Pharma Segment overseeing compliance issues regarding large molecule products as well as serving on Proactive Compliance and PV Lifecycle Implementation teams. Shawn also served in the US Food and Drug Administration’s Office of Compliance where he worked on the pre-approval process for new and generic drugs with special emphasis on applications involving QbD and PAT concepts. He also served on FDA working groups relating to Quality Systems, the PAI process, Strategic Planning, and Lean Operations within the agency.
Tara Scherder has over 20 years of experience in the pharmaceutical and biopharmaceutical industries as a statistician, process engineer, and master black belt. Her passion is the powerful combination of science and statistics to increase knowledge, optimize both manufacturing and business processes and reduce risk. She combines statistical expertise with extensive knowledge of manufacturing platforms, and analytical sciences, in conjunction with business and regulatory acumen to achieve goals. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams from product development through commercial supply for the spectrum of product platforms. She frequently speaks at industry forums and publishes on the practical incorporation of statistical methods for Lifecycle Process Validation.
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
Steven Wisniewski is Principal Consultant for CAI Consulting, a highly respected provider of consulting and technical services for biotech and pharmaceutical manufacturers worldwide. CAI Consulting focuses on the manufacturing lifecycle process, with services including commissioning, validation, technology transfer, owner Project Management, maintenance programs, SOPs, training and cGMP compliance. Wisniewski has more than 35 years’ experience in the pharmaceutical, biotech, and device industries.