In-Depth Pharma Training in Huntington Beach

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.   

ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course

13 - 14 Dec

This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. The course also discusses the manufacturing equipment system and engineering practice and compliance issues. Participants will learn key regulatory information and practical utilization techniques to develop the ability to ask the right questions based upon science and the regulations knowing the relationship between this quality guidance for the production of APIs, and GMP regulations applicable to the production of pharmaceutical and biologic finished drug products.

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Risk-Based (Quality Assurance) Verification of Facilities, Systems and Equipment Workshop

13 - 14 Dec

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.

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Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles - Updated

13 - 14 Dec

Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products. The course includes a review of biopharmaceutical manufacturing facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy. Participants will discuss current case studies on a wide array of facility topics, and complete class exercises that involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements.

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An Overview of Biopharmaceutical Manufacturing Processes - Updated

13 - 14 Dec

This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion and adsorptive chromatography.

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