Deep Dive Pharma Training Course 

Join us during the 2019 ISPE APAC Pharmaceutical Manufacturing Conference as we take a deeper dive into critical areas of the pharmaceutical industry. 

GMP Fundamentals for the Pharmaceutical Industry Training Course

2 - 3 Oct

This classroom course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process. This includes a discussion of the FDA Systems Based Approach to inspections (Compliance Document 7356-002). In addition, participants will investigate the science behind the requirements, the people side of GMP, the challenge of defending products against contamination, how to consistently build quality into products, and how to personally audit for GMP compliance and performance. The course will conclude with a discussion on the basic GMP requirements related to facility and equipment controls.

Participants can expect open class discussions, sample problems, and an examination of the text of the regulation CFR 21, Parts 210 and 211 and/or the EU GMP guidelines. Throughout the course, we will emphasize positioning GMP as a tool for successfully coordinating, controlling, and improving quality, and developing regulatory control strategies. GMP will be presented as an opportunity to integrate product quality and regulatory compliance with performance. The course will provide all participants with the confidence to apply GMP to their specific job responsibilities and the comfort level to interact with fellow employees concerning GMP issues, as well as build a foundation for making GMP a lifestyle at their companies.Through hands-on exercises and lectures, you will discuss and explore GMP principles and approaches for active pharmaceutical ingredients (APIs), excipients, and finished pharmaceuticals. Learn easy-to-grasp basics of regulatory requirements, current issues, and trends in the pharmaceutical industry with an emphasis on applying GMP in day-to-day operations. 

After understanding the "whys" behind the GMP regulations, participants discuss the history of the GMP regulations, the regulatory process, and the concept of operating in a "state of control," with an emphasis on the regulation of pharmaceutical products. 


Registration
Member $ 1355
Nonmember   $ 1355
Academia/Government   $ 650
Student  $ 98


Mail or Fax Registration

Not paying by credit card? Use the registration form to pay by mail or by fax.

Group Discount Rate

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.


ISPE Professional Development

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.   

Learn more about all of the professional development opportunities available through out the year around the globe.