Bulk Biologics and Active Pharmaceutical Ingredients (QLP Module 5)

About this course

The quality of a medicine depends in no small part on the quality of its ingredients, and in particular the drug substance. Thus, the Quality Leader and other key professionals in drug product manufacture must have a thorough understanding of how the manufacture and control of drug substances and their supply chain may influence the fitness for use of the drug product.
This is applicable for drug substances derived from both chemical synthesis and biological or biotechnology origins, but there are significant differences between the two.

The need for product and process understanding is recognized by the regulators, and places the responsibility for assuring the quality of the drug substance firmly on the shoulders of the drug product manufacturers and their quality systems, with certain expectations specifically for the quality professional.
This course is designed to provide you with the knowledge and understanding to fulfil your responsibilities with competence and confidence.

How This Training will Benefit You

It will provide the background and knowledge needed by every Quality Professional and Technical Leader whether in Production, Quality, R&D, Validation, Engineering, or any other technical discipline. As with all of NSF-DBA’s courses, it is led by industry and academic experts; frequently incorporating case studies and small group sessions to facilitate learning.

NSF-DBA’s format of extended days and pre-work ensures that both you and your company benefit from the learning experience in an efficient way and with minimal time away from the workplace.

The Quality Leadership Program and this module on Bulk Biologics and Active Pharmaceutical Ingredients is based upon a key component of the Qualified Persons instruction which NSF-DBA offers in Europe. It sets a new standard for practical, results oriented instruction.

A Certificate is granted by NSF-DBA for attendance. Higher degree options – a Diploma and a Masters in Pharmaceutical Quality and Good Manufacturing Practice from the University of Strathclyde can be obtained by attending the full series.

Continuing Education Credit
‘Bulk Biologics and Active Pharmaceutical Ingredients’ offers Quality Professionals knowledge learning and an enhanced understanding of the Pharmaceutical Industry.

ACPE Continuing Education Units = 2.4 CEUs
Reference Activity Number 0616-0000-10-004-L04-T

Course outline

Active Pharmaceutical Ingredients

• The Regulations
  • US and EU regulations and guidelines
  • Drug Master Files and Certificates of Suitability
  • Key GMP guidance – ICH Q7

• Manufacturing Processes and Quality
  • Key issues for…
    • Synthesis
    • Purification and impurity control
    • Packaging
  • Process validation

• Supply Issues for the Dosage Form Manufacturer
  • Supplier selection and audit
  • Supply chain integrity
  • Technical Agreements
  • Certificates of Analysis

Bulk Biologicals and Biotech Products

• EU and US Regulatory Aspects and Key Guidances
• Essential Characteristics of Biologicals
  • Antibiotics
  • Vaccines
  • Blood products
  • Monoclonal antibodies
  • Recombinant DNA products
• Quality Aspects
  • Control of starting materials
  • Control of cultivation and purification
  • Analytical techniques to judge quality
• Excipients
  • Regulatory environment
  • GMP guidances/codes

Discussion and Working Groups

A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Venue

Royal Sonesta Hotel Boston, MA, USA

The Royal Sonesta hotel is minutes from downtown Boston. Located
along the Charles River, it is close to many of the Boston historic sites,
including the Boston Science Museum. There is excellent shopping
nearby.

Hotel Accommodation

NSF-DBA has negotiated a preferred rate with the Royal Sonesta
Hotel. A limited number of rooms are available at this rate. Hotel
reservations and payment are the responsibility of each delegate.
We will be happy to help but final confirmation and bill settlement
is the delegate’s responsibility.

There are a number of other hotels located within minutes from the
Royal Sonesta Hotel including the Marriott Hotel, the Courtyard Inn
and Le Meridien Hotel, all situated in Cambridge. Downtown Boston
hotels are within 15 minutes by taxi or public transportation of the meeting venue.

_{Royal Sonesta Hotel, 40 Edwin Land Blvd., Cambridge, MA 02142, Tel: 617-806-4200.}

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• Dr Robert Pietrowski
  Managing Partner
  BSc, PhD, CBiol, MIBiol

  • [email protected]
  • +44(0)1751 432999
• 

  Mr Neil Wilkinson
  Senior Partner
  CChem, MRSC

  • [email protected]
  • + 1 617 342 3625

What you've said

What Previous Attendees Said About Our QLP Courses

“Outstanding course! I will be recommending the program to my colleagues and registering my direct reports. Workshops are effective in exchanging industry experience and promoting team and group cohesion and good dynamics”

Jose Torres, OPK Biotech

“Course instructors and professors are always excellent. Thank you for another great course. I found the pre-read material very helpful in preparing for the class”

Debra Lane, Shire

“This course was great! The information presented was very applicable and the presenters were very knowledgable. A good mix of lecture and teamwork exercises. I enjoyed the stories of the presenters and their sharing of personal experiences”

Charles Carlile, Watson Pharmaceuticals

“It is an exceptional opportunity to participate in a development course which includes instructors with ‘real’ industry experience and much history collaborating with regulatory bodies”

Paula Blalock, Alelrgan Inc