In-Depth Pharma Training in Manhattan Beach

Deep Dive Pharma Training Courses 

Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.

  • Real World Practice:  Courses present exercises that use current problems and situations common to the industry.
  • Experienced Instructors:  Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
  • Global Training to Fit Your Needs:  With classroom, eLearning and onsite training options available, ISPE training courses adapt to any schedule or location.   

Cleaning Validation Principles

16–17 Apr 2019

As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. With the FDA's risk-based regulatory initiatives focusing new attention on the risks of cross-contamination understanding lifecycle management techniques for an effective cleaning validation program is paramount. This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.

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Instructor

Rebecca Brewer has more than 29 years of experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries. She began work with Quality Executive Partners, a boutique consultancy to make a difference in pharmaceutical consulting in 2013. Prior to working with Quality Executive Partners, Becky was Director of Consultancy and GMP Compliance with Dober, where she assisted customers with challenging validation and compliance problems, including Cleaning Validation. Becky has had the opportunity to audit, develop and provide training in validation and compliance programs for a large variety of companies and products. She is the current instructor for ISPE’s Cleaning Validation Educational course and PDA’s Biotechnology Cleaning Validation course. She also frequently conducts site-specific validation and GMP compliance training for individual companies.


A GAMP® Approach to Data Integrity, Electronic Records and Signatures, and Operation of GxP Computerized Systems

16-18 Apr 2019

The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

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Instructor

Dr. Perez retired at the end of 2015 from the position of Director, Information Governance and Management for Novartis Pharmaceuticals. His responsibilities at Novartis included a wide range of IT Compliance issues, such as GxP, Sarbanes-Oxley, and data privacy. He served on several global Novartis teams dealing with computer systems compliance issues, and authored many of the firm's global GxP compliance policies. During his 32-year tenure at Novartis, he developed a broad range of experience. He was part of the core team that led the development of GAMP® 5, published in 2008. In addition, he initiated and led the Global Information Systems SIG, who wrote a GAMP® Good Practice Guide that was published in 2005, and he led the team that developed the second edition of this guide that was published in 2017. He was the lead author of the 2014 GAMP® GPG “A Risk-Based Approach to Regulated Mobile Apps,” and was part of the core author team for the 2017 “ISPE/GAMP Guide to Record and Data Integrity.”


HVAC

16-18 Apr 2019

This classroom course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more. Participants will review global cGMP regulations, including an update of ISO14644-1 & 2 reflecting 2015 changes, as well as common interpretations of those regulations and how they may apply to their facilities. The class will explore critical issues at each stage of the product lifecycle, from R&D to Manufacturing, such as: controlling cross-contamination between products, determining the correct classification of spaces, proper control of storage temperature and humidity, setting acceptance criteria for HVAC systems and using risk assessment to set environmental criteria. Workshops that include templates will be provided to help participants immediately apply what they have learned.

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Instructor

Norman Goldschmidt is President and Sr. Principal at Genesis Engineers. He has over 30 years of experience in engineering management, planning, design and construction in the pharmaceutical and biotech industry. Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing. Mr. Goldschmidt studied Engineering Management at the State University of New York and Mechanical Engineering at the University of Buffalo. He holds 4 patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) delegate, Adjunct Professor at the New Jersey Institute of Technology, Lead Author of the ISPE Good Practice Guide for HVAC as well as author, contributor and instructor for ISPE, ASHRAE, David Begg Associates and others.


Pharmaceutical Water Generation

16-17 Apr 2019

This classroom course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation. Participants will examine methods for proper water quality selection, information on compendial and non-compendial waters, fundamentals of basic water chemistry, and information on common unit operations (deionization, reverse osmosis, and distillation). Pre-treatment systems, detailed guidance for selection of construction materials, and operations issues related to pharmaceutical water generation systems will also be discussed.

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Instructor

Andrew Collentro is Technical Director for Water Consulting Specialists, an engineering and consulting firm serving the pharmaceutical and biotechnology industries. He has more than 15 years of experience in the design, commissioning, and qualification of pharmaceutical water purification systems; specializing in process design and regulatory compliance of USP Purified Water and WFI Systems. Collentro is a member of the ISPE Training Faculty, and has taught courses for PDA and other industry organizations. He is also a Chapter Leader for the ISPE Baseline® Guide for Water and Steam Systems and past Chair of the ISPE Critical Utilities Community of Practice (CoP).


Storage, Delivery and Qualification of Pharmaceutical Waters

18–19 Apr 2019

This classroom course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the ISPE Baseline® Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging. The course material will cover methods for determining the appropriate distribution and storage strategy, including sanitization method, for various operating circumstances including an overview of optional distribution approaches and the advantages and disadvantages of each. Microbial control characteristics of the various distribution systems will be presented and compared. Point-of-use service and sample point design, materials of construction for distribution and storage systems, and instrument components will also be covered.

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Instructor

Andrew Collentro is Technical Director for Water Consulting Specialists, an engineering and consulting firm serving the pharmaceutical and biotechnology industries. He has more than 15 years of experience in the design, commissioning, and qualification of pharmaceutical water purification systems; specializing in process design and regulatory compliance of USP Purified Water and WFI Systems. Collentro is a member of the ISPE Training Faculty, and has taught courses for PDA and other industry organizations. He is also a Chapter Leader for the ISPE Baseline® Guide for Water and Steam Systems and past Chair of the ISPE Critical Utilities Community of Practice (CoP).


Process Validation in Biotechnology Manufacturing

18-19 Apr 2019

The inherent complexity and uncertainty of biotechnology make developing and validating bioprocesses for manufacturing proteins and biopharmaceuticals very difficult. Understanding and using FDA's Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products. This classroom course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes. Topics include a comprehensive strategy to process validation; a review of important biotechnology manufacturing processes, and the regulatory requirements for their validation.

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Instructor

Jefferey Jones, Executive Director of Quality at Humacyte, Inc., has over 20 years of experience with development-stage and commercial biopharmaceutical process technology transfer. In his current role, Jefferey oversees Quality aspects of facility, process, and instrumentation design and scale up for a novel biologic process manufacturing bioengineered blood vessels. Prior to his work at Humacyte, Jefferey was responsible for Manufacturing Operations, Quality Assurance/Control, and Validation at Emergent Biodefense in Lansing, Michigan. Jefferey previously held positions overseeing Quality Assurance, Quality Control, and Product Development activities at MedImmune, Inc. and Human Genome Sciences. Jefferey earned a Bachelor of Science degree in Biology from Virginia Polytechnic Institute and State University and a Master of Science degree in Biotechnology from The Johns Hopkins University.


Risk-Based Verification of Facilities, Systems and Equipment Workshop

18-19 Apr 2019

The successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. This interactive classroom course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program. Through interactive workshops, participants will more fully understand and apply the principles of ASTM E2500-07 and ICH documents (Q8 (R2), Q9, and Q10)to the documented verification of pharmaceutical and biopharmaceutical facilities, systems and equipment that are suitable for their intended purpose. Templates will be developed to facilitate the translation of the scientific knowledge about the product and process into documented specification, design, and verification of facilities, systems, and equipment.

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Instructor

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. He holds a BSME from Rensselaer Polytechnic Institute, is an active Member of PDA and has participated on a Technical Report draft team, and an active Member of ISPE. He served on the ISPE board of directors beginning in 1982, and was chairman of the board in 1991. Wisniewski served four years as chairman of the ISPE Community of Practice for Commissioning and Qualification, and was on the ISPE task team that developed the ASTM E2500 Verification Standard.


Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

16-17 Apr 2019

Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process; producing high quality products and consistent operation to meet product user requirements. Guidance on the transition of an organization’s approach to Commissioning and Qualification to one that incorporates a science and risk-based approach will be discussed.

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Instructor

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. He holds a BSME from Rensselaer Polytechnic Institute, is an active Member of PDA and has participated on a Technical Report draft team, and an active Member of ISPE. He served on the ISPE board of directors beginning in 1982, and was chairman of the board in 1991. Wisniewski served four years as chairman of the ISPE Community of Practice for Commissioning and Qualification, and was on the ISPE task team that developed the ASTM E2500 Verification Standard.