NUSAGE – PharmEng
Pharmaceutical and Biotechnology
Training Program
www.NUSAGE.nus.edu.sg | Copyright © 2014 NUSAGE-PharmEng.
PHARMACEUTICAL AND BIOTECH
MANUFACTURING PROCESSES
Shaping Human Capital for
Challenges in the Pharmaceutical
Industry
www.NUSAGE.nus.edu.sg | Copyright © 2014 NUSAGE-PharmEng.
PHARMACEUTICAL AND BIOTECH
MANUFACTURING PROCESSES
www.NUSAGE.nus.edu.sg | Copyright © 2014 NUSAGE-PharmEng.
Objective
This course covers technologies associated with pharmaceutical and biotechnology processes
and different dosage forms. Manufacturing processes and unit operations, facility, personnel,
and microbial and quality control requirements will be reviewed with focus for pharmaceutical
and biotechnology processes.
Description
To provide an understanding of different processes that is part of the pharmaceutical and
biotechnology facilities. Specific processes will be presented in details along with industry
examples.
www.NUSAGE.nus.edu.sg | Copyright © 2014 NUSAGE-PharmEng.
Course Details
Instructor: Dr Rick Ng
Date and Time:
15 - 16 October 2015 | 9AM – 5PM
Course Outline
• Sterile Products/Dosage Forms
• Liquid dosage forms, Semi-solid dosage forms
• Solid dosage forms (e.g. solid fill, freeze-dried)
• Non-sterile products/Dosage Forms
• Liquid dosage forms
• Semi-solid dosage forms- topicals (creams, ointments, gels, etc.)
• Solid dosage forms (unit dose form (tablets, capsules, suppositories, etc.), multi dose form (powders,
granules)
• Biological products Dosage Forms, Vaccines, Blood products, Other (e.g. hormones, enzymes of human or
animal origin, genetically engineered products)
• Dispensing, Granulating, Drying, Blending, Compressing, Coating, Mixing,
• Material Transfer, Filling, Clean-in-Place, Steam-In-Place
• Upstream Processing in Biotech facility, Downstream Processing in Biotech facility
• Media Preparation, Fermentation, Separation, Purification
• Lyophilization, Filtration, Aseptic Filling
• Sterilization Processes (e.g. Steam Sterilization Autoclaves, Dry Heat Sterilization, Depyrogenation)
Learning Outcome
Upon completion of this course the attendees will be able to:
1. Identify and classify the various dosage forms in pharmaceutical and biotechnology processes
2. Gain an overview of the key unit operations that make up the manufacturing process of each dosage
form (for example, in the case of solid dosage form, an overview of blending, mixing, coating, drying,
and tableting steps)
3. Gain an overview of key microbial and quality control attributes that are related to each dosage form
and its unit operations
4. Learn to apply the knowledge in facility and manufacturing planning, identifying critical points in a
process, identifying quality control plan, and identifying the validation plan.
Dr. Rick Ng holds degrees in BSc (Honours), PhD and MBA. He has worked in senior positions in Clinical, Quality,
Regulatory Affairs and Business Development in the biotech and pharmaceutical industry in Australia and Singapore
for more than 20 years. Currently Rick provides consulting and training services in GCP, GMP, Quality, Regulatory
and Validation. Rick is the author of one of the best selling medicine/pharmacology books, Drugs: From Discovery to
Approval, which is a recommended text in a number of universities/colleges.
PHARMACEUTICAL AND BIOTECH
MANUFACTURING PROCESSES
www.NUSAGE.nus.edu.sg | Copyright © 2014 NUSAGE-PharmEng.
Registration Form
Please complete details below clearly.
Full Name & Title* (Prof. /Dr. /Mr. /Mdm/Ms.) _______________________________________
Job Title ___________________________ % Knowledge on Subject Matter _________________
Company __________________________________________________________________________________
Business Address ___________________________________________________________________________
Business Tel. _____________________________________ Mobile No. ______________________________
E-mail Address _____________________________________________________________________
Special Diet* (Non-spicy / Vegetarian / Vegetarian without egg / No beef / Halal / No preference)
* Circle where appropriate
Fees:
S$1070 per delegate after GST.
Early bird registration discount 14 days before the course or
group discount of 5 or more delegates: 10% off per delegate
Course fee includes course materials, tea breaks and lunch.
Please return completed forms by mail/fax to:
National University of Singapore
NUSAGE
Department of Pharmacy
S4, Level 2
18 Science Drive 4
Singapore 117543
Fax: 67791554
For inquiries, email
[email protected] or dial 65168977
Payment:
Only cheques are accepted. Please make cheques payable
to:
“National University of Singapore”
Payments must be received at least one week prior to event.
Cancellations must be made in writing. If cancellations are
received 2 weeks prior to course, a full refund, minus a
handling fee of $75 will be issued. No refunds will be granted
thereafter. Substitutions are acceptable if the registrant is not
able to attend.
Registration is subjected to confirmation. Registrants will be
notified upon confirmation on venue and payment matters.
We apologize in the event of changes to the instructor or date
of event due to unforeseen circumstances, of which
registrants will be duly informed and any payment received
will be refunded.
PHARMACEUTICAL AND BIOTECH
MANUFACTURING PROCESSES
ABOUT THE TRAINING PROVIDER
www.NUSAGE.nus.edu.sg | Copyright © 2014 NUSAGE-PharmEng.
PHARMENG TECHNOLOGY
PharmEng Technology (“PharmEng”), a division of PEPharma Inc., provides professional development and
certification training programs throughout North America and Asia. We deliver over 35 courses to the
pharmaceutical, biotechnology, nutraceutical and medical devices industries in the areas of:
cGMPs
Validation
Engineering
Project Management
Medical Devices
Quality Compliance
Quality Assurance
Regulatory Affairs
Manufacturing
Why PharmEng Professional Training?
Unique curriculum that covers key areas critical to the success of the industry, through courses that
integrate theory and practice
Advisory committee that includes members from industry, academia and government, ensuring that
important regulatory and industry issues are addressed
Custom courses that cover both general and basic “know-how” as well as current challenges, issues
and new developments in the industry
Instructors that have been selected among industry leaders and subject experts who will provide
challenging course work and valuable hands-on experience
PharmEng delivers courses to two distinct groups:
1. Corporate Training: Experienced industry professionals who require current best practices in order to
keep up-to-date with industry standards, Good Manufacturing Practices (GMP’s) and regulations.
2. Career Training: Next generation individuals seeking careers in the industry who need practical skills
and “know-how” for the pharmaceutical and biotechnology workforce.
For those individuals requiring one day professional development programs, courses are available through
any of the PharmEng offices located throughout North America and Asia with access to course listings,
course availability and registration through the PharmEng website www.pharmeng.com.