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

phacyy@nus.edu.sg 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.