Biotechnology Workshops
Ohlone College is once again offering training workshops for biotechnology industry employers and employees. The training is designed to enhance skills in various topics relating to biomedical, medical devices, diagnostics, pharmaceutical, and other areas. These workshops are taught by industry professionals with extensive hands-on experience and are funded by an Economic and Workforce Development grant from the California Community College Chancellor’s Office.
Summer 2008 Biotechnology Workshops
Workshops are either one, two or three full days. Workshops are held at various locations; however, hands-on workshops are taught at the Ohlone campus laboratories.
- ELISA Basics Workshop
- Biotechnology for Non-Scientists
- Writing SOPs
- Good Manufacturing Practices
- Intro to Stats for QA/QC - Intermediate
- Quality System Reg.-Medical Devices
- Intro to Stats for QA/QC - Basic
- Intro to Stats for QA/QC - Advanced
Additional workshops to be announced!
Workshops with an asterisk (*) are only partially supported by the grant and therefore require a fee. All other workshops are free.
All workshops have hands-on applications and practice. Some workshops have laboratory activities as applicable.
Space is limited to 20 participants - see registration information. Deadline to register is 3 days before each workshop.
Bios for Biotechnology Workshop Instructors (PDF).
Workshop Schedule
Download the Summer 2008 Biotechnology Workshops Schedule, Locations, and Registration Form (PDF) (view with the free Adobe Reader software) (July through August 2008) and workshop descriptions.
For more information, call (510) 659-6184.
Workshop Locations
- Ohlone College
Fremont Campus
43600 Mission Boulevard
Fremont, CA 94539 - Ohlone College Newark Center
39399 Cherry Street
Newark, CA 94560
Biotech Workshops Descriptions - Summer 2008
Introduction and Review of Quality System Regulations for the Medical Device Industry (Basic GMP and ISO-Medical Devices): A two-day workshop that provides an introduction to, or a review of, the two most important quality system regulations that govern medical device design and manufacturing: the "Good Manufacturing" (GMP) regulation required by the US FDA (21CFR820) and the "ISO 13485:2003" standard required by the European Commission. Those two documents apply to start-ups as well as established companies if they wish to market products in the USA or Europe, respectively. The format of the workshop is the reading of the regulation/standard, word by word (they are not long), combined with explanations of the meaning of the text, as well as discussion of illustrative examples of the wrong and right ways to implement them. The examples will be provided by the instructor and any students who would like to contribute. Students will conduct real-life situation evaluations. The workshop does not require prior regulatory training. Wednesday and Thursday, July 30 and 31- 8:30 am to 4:30 pm. Ohlone College Newark Center, 1st floor, Room 1100 – No Fee.
Good Manufacturing Practices (cGMP) for Biopharmaceutical Drugs: This two-day introduction to cGMP is designed for biopharmaceutical personnel. It is suitable for professionals responsible for compliance, regulatory affairs, project planning, QC/QA, R&D, and manufacturing. Participants will learn through lectures, case study discussions, and group exercises. Current approaches to quality, SOPSs, documentation and records basics, quality requirements and exceptions, inspections and audits including FDA and European approaches will be covered. It covers 21 CFR 210, 211 and brief overview of Eudralex. Monday and Tuesday, August 4 and 5 – 8:30 am to 4:30 pm. Ohlone College Newark Center, 1st floor, Room 1100 – No Fee.
ELISA Basics Workshop: The objective of this workshop is to understand and master the experimental concepts and methodology involved with various ELISA Assays. This workshop is useful for Biotechnologists and Health Science professionals. It would be of utmost importance to Research Associates, those who use Immunological Screening Test in University Research and to Scientists who study proteins specifically Antigen/Antibody Binding. Specific topics that will be covered are: Introduction to Antigen Antibody Interactions, Specificity of Antibodies, Different types of ELISA, Effect of dilution on ELISA reactions, and Quantitative ELISA Lab Activity. Thursdays, August 21 and 28 – 1:00 pm to 5:00 pm. Ohlone College Newark Center, 2st floor, Room 2424 – No Fee.
Biotechnology for Non-Scientists: This workshop will provide participants with an introduction to the language and basic concepts of molecular biology, cell biology, and genetics - the foundations of modern biotechnology. Participants will learn what monoclonal antibodies are and what they’re used for, the difference between small molecule drugs and biological therapeutics, the secrets of recombinant DNA technology, stem cell biology, and more. There will be hands-on laboratory activities that include DNA isolation and practice with some of the basic tools of the biotechnology lab. Friday, August 22 – 9:00 am to 4:30 pm. Ohlone College Newark Center, 2st floor, Room 2418 – No Fee.
Writing SOPs: One full day of lecture and discussion. Failure to follow one’s own procedures continues to be the single most-cited violation of the GMP regulations. Meanwhile, despite numerous re-write attempts and multiple reviewers, many SOPs are not well-written or easy to follow. Examples of effective and problematic technical writing will be used to illustrate common pitfalls and highlight best practices. Participants will have the opportunity to critique writing and write a draft procedure. Monday, August 25 – 8:30 am to 4:30 pm. Ohlone College Newark Center, 1st floor, Room 1100 – No Fee.
Introduction to Statistics for QA/QC – Basic: This one-day workshop provides an introduction to, or a review of, the most commonly used basic statistical methods and tools used in the biotech industry. The major topics covered include review of relevant regulatory requirements, basic statistical vocabulary and concepts, probability, Law of Large Numbers, distributions, standard deviation and standard error, normality. There will be a quiz. A working knowledge of algebra is a prerequisite, but prior statistical training is not. The instructor will hand out a few MS Excel files for student-use either in class or at home. Students are encouraged to bring a laptop (and extension cord) to the class, but this is not a requirement. Tuesday, August 26 – 8:30 am to 4:30 pm. Ohlone College Newark Center, 1st floor, Room 1100 – No Fee.
Introduction to Statistics for QA/QC – Intermediate: This one-day workshop provides an introduction to, or a review of more advanced statistical concepts and on formal statistical methods and tests: t-tests, reliability calculations, tolerance limits, significance, confidence, confidence intervals, statistical “power”, and normal transformations. There will be a quiz. Pre-requisite: Previous completion of Basic Statistics workshop or equivalent training and/or experience. Students are encouraged to bring a laptop (and extension cord) to the class, but this is not a requirement. Wednesday, August 27 – 8:30 am to 4:30 pm. Ohlone College Newark Center, 1st floor, Room 1100 – No Fee.
Introduction to Statistics for QA/QC – Advanced: This one-day workshop will instruct how to perform basic statistical tests and comparisons, how to choose QC sampling plans, how to create and use SPC charts, and how to evaluate your current calibration program for effectiveness and compliance with regulatory requirements. Reliability Plotting, SPC (Statistical Process Control) and Process Capability calculations, sampling plans, and statistical control of measurement equipment used in the biotech industry will be covered. There will be a quiz. Pre-requisite: Previous completion of Intermediate Statistics workshop or equivalent training and/or experience. Students are encouraged to bring a laptop (and extension cord) to the class, but this is not a requirement. Thursday, August 28 – 8:30 am to 4:30 pm. Ohlone College Newark Center, 1st floor, Room 1100 – No Fee.
Ohlone College campus maps: Fremont campus, Newark Center campus.
Registration Information
- To register, complete the Biotechnology Workshops Registration Form (PDF), print the form, complete it, and then fax it to (510) 659-6446. An email will confirm our receipt of the registration.
- Workshops with fees require online registration. Go to: http://commed.ohlone.edu, click on ‘Courses’ (in the left hand menu), and then click on ‘Biotechnology Workshops’. You may also submit a Workshop registration form, but enrollment is not official until payment is received.
- Space will be limited to the first 20 applicants with a registration form completed, including phone number and email address.
- Confirmations will be emailed 5 days before the start of each workshop.
- A waitlist will be initiated once the limit of 20 students is reached at each workshop. Students on the waitlist will be contacted, in the order received, when and if there are any cancellations.
- Registered students are required to cancel in the event that they cannot attend a workshop 24 hours in advance. We request all registered participants’ cooperation in this respect. We strive to accommodate each and everyone.
- We reserve the right to cancel any workshop for lack of enrollment or unforeseeable circumstances. We will email/call each registered participant in the event of a cancellation.
- We can offer these workshops on-site, in which case we require a minimum number of participants and laboratory access, as applicable.
- For registration information: Call (510) 659-6184, or email: workshops@ohlone.edu
Some of the workshops are often repeated due to high demand and new workshops are added throughout the year. Check the Biotechnology Workshops web page periodically.
