Why Should I Attend This Class?
This foundational certification provides essential knowledge of regulatory expectations in the pharmaceutical and biomanufacturing industries. Designed for individuals new to Good Manufacturing Practices (GMP) or interested to refresh their GMP knowledge, this course introduces key regulatory bodies, compliance systems, and documentation requirements necessary to work in GMP-regulated environments.
What Will I Learn?
Upon successful completion of the program, participants will be able to:
- Understand the role and history of the FDA and global regulators.
- Describe the core principles of GMP, GDP, and GLP.
- Recognize essential components of 21 CFR Part 211.
- Demonstrate an understanding of documentation systems and data integrity standards (ALCOA & ALCOA+).
- Gain insights into drug and biologic development, including cell and gene therapy.
- Apply knowledge through real-world case studies and observations.
Who Should Register for This Class?
This class is a great introduction for anyone interested in obtaining basic knowledge of large-scale biomanufacturing or pharmaceutical operations in a simulated GMP environment, including:
- Personnel who are interested to join pharmaceutical industry
- Pharmaceutical personnel who wish to gain certifications that will advance their career opportunities
- New biomanufacturing/ pharmaceutical employees
- Incumbent workers looking to enter the biomanufacturing/pharmaceutical industry
What are the Pre-Requisites for this Course?
Students registering for this class must have earned or in the final grade to earn a High School Diploma and must complete English as a Second Language (ESL) if they do not read, speak, or understand the English language.
What Will I Gain from this Course?
- 15 hours of instruction
- All lecture material printed
- Exposure to industry partners and networking opportunities
- Certificate of Completion
Lead Instructors
Instructors include pharmaceutical industry partners and subject matter experts.
What is the Cost of this Course?
$695
Is there a scholarship available for this course?
Scholarships will be available based on eligibility. Please contact Shannon Woodruff shannon.woodruff@raritanval.edu
What is Waitlist Policy for this Course?
If the course is full your registration, you are welcome to email and asked to be placed on a waitlist. This waitlist is used to fill any seats that may become available when students withdraw from the class. When seats become available, students are selected on a first come first serve basis.
In addition to ensuring courses remain full, our waitlist provides a means of tracking your interest and determining if additional sessions are required. Placement on a waitlist does not commit you to attending the course, but does reserve a spot if you are interested when a seat becomes available.
RVCC is not able to provide information regarding the number of students placed on our waitlist or your place on the waitlist.
Click here to join our waitlist: GMP Professional Certificate
Am I Eligible for a Discount?
A 10% discount is available to students who are employed by a sponsoring industry partner.
How Can I Pay for this Course?
Payment for the course is required prior to the course start date to ensure a spot is saved for you in our class. RVCC accepts payment from all major credit cards including American Express, VISA, and MasterCard. Checks are also accepted but must be clear prior to the class start date.
Some individuals may be eligible for scholarships for our classes. Please contact shannon.woodruff@raritanval.edu to see if you are eligible.
What is the Cancellation Policy for this Course?
If you have questions regarding the cancellation policy, please contact our administrator.
Who Can I Contact if I have Questions Regarding this Course?
Please contact our course administrator, Shannon Woodruff at shannon.woodruff@raritanval.edu with any questions or concerns you have regarding this program.
You will receive an email from our administrator upon registration to confirm your spot in our course.