Parenteral Products
Three Day Intensive Course Covering Formulation, Product Development,Sterile Manufacture and Quality Assurance with Special Emphasis on Formulation, Biotechnology Products, Operational and GMP Issues and Sterilisation Processes.
This Course will provide an overview of the design and manufacture of a range of parenteral products, with a mixture of lectures, case studies and workshops. The workshops are designed to encourage interaction between delegates and presenters and to enhance participants understanding of specific key aspects of parenteral products. The course will cover routes of parenteral administration, types of parenteral product, common formulation strategies and relevant regulatory guidelines.
The formulation of biological and freeze dried products will also be discussed as well as primary packaging and delivery devices.
The discussion of parenteral product manufacture will include problems encountered in the production environment, sterilisation, depyrogenation, media simulations and the quality assurance of parenteral products. The Course will also outline the use of isolators and access barriers for aseptic processing and discuss the quality criteria for water for injections. GMP requirements and regulatory expectations specific to parenteral products and sterile processing will be discussed throughout the course.
A feature of the Course is the Workshops designed to enhance participant"s understanding of specific aspects of Parenteral Products
Summary of Key Benefits of Attending
After attending the course participants should be familiar with:
- Routes of parenteral administration and the different types of parenteral product
- Critical Quality Attributes for parenteral products
- Common formulation strategies for parenteral products, including approaches to overcome solubility and stability challenges and to meet sustained release criteria
- Formulation and analytical approaches in the development of biological products
- Formulation and manufacture of freeze dried products
- Parenteral product primary packaging and administration devices
- Sterilisation and depyrogenation processes
- Cleanroom standards and environmental monitoring
- The control of Water For Injection and clean steam systems
- Principles of quality control, quality assurance and documentation in relation to parenteral products
- Process validation
- GMP and Regulatory requirements for the development and manufacture of parenteral products
Product Development and Formulation
- Routes of Administration
- Types of parenteral product
- Sterility considerations in parenteral product development
- Target product profiles and quality attributes
- Simple solution formulations
- Formulating poorly soluble drugs
- Formulating poorly stable drugs
- Slow release parenteral products
Biotechnology Products
- Special considerations when formulating and developing macromolecules
Primary Packaging and Devices for Parenteral Products
- Types of devices for administration
- Compatibility issues
Freeze Drying
- Theory and practice of freeze drying
- Formulation and development of freeze dried products
- Freeze drying in a production environment
Sterilisation, Depyrogenation and Sanitation Techniques
- Moist and dry heat sterilisation processes
- Chemical sterilisation and disinfection
- Irradiation
- Depyrogenation technologies
Filters and Parenteral Products
- Filtration mechanisms and filter types
- Product compatibility and process development
- Integrity testing
Cleanrooms, Isolators and Barriers
- Cleanroom standards and design
- Aseptic processing considerations
- Environmental monitoring and control
- Isolators and Restricted Access Barriers
Critical Utilities
Validation
- Process validation
- Process simulations
- Production and control of water for injection
- Clean steam attributes
Regulatory
- Regulatory expectations
- GMP issues
- Quality Assurance
The course will include workshops on specific aspects of Parenteral Products
COURSE SPEAKERS (View profiles on ‘Our Experts’ page)
Peter Cameron (Course Director)
Joanne Broadhead B.Pharm., Ph.D.
Keith Wickert B.Sc (Hons)
Andy Donnelly Ph.D.
Eddie J French Ph.D.
PARENTERAL PRODUCTS Experts
Peter Cameron (Course Director)
Mr Cameron has worked for the last 20 years as a Pharmaceutical and Healthcare Consultant, originally within the Pharmaceutical Division of Bovis Lend Lease and more recently with his own company, 3CP. He specialises in parenteral production operations, regulatory issues and validation. He has been associated with the production of sterile products for over 40 years, during which time he worked for Parke Davis as a Technologist with special responsibility for parenteral validation and process development and CAMR, managing the production of clinical trial material. Mr Cameron is a member of the Pharmaceutical and Healthcare Sciences Society of Great Britain, freeze drying special interest group and been closely involved in the production of many of the society"s monographs. He has edited and contributed to a book on Good Pharmaceutical Freeze Drying Practice.
Joanne Broadhead B.Pharm., Ph.D.
Dr Joanne Broadhead is an Independent Consultant specialising in parenteral product development and manufacture. Prior to forming her own consultancy company in 2011, she worked for many years in the Product Development group at AstraZeneca. Within AstraZeneca she led both formulation and manufacturing teams and from 2006-2011 managed the pilot scale parenteral manufacturing facility at the company"s Charnwood site. Joanne is a registered Pharmacist and co-chair of the Parenteral's Focus Group of the Academy of Pharmaceutical Sciences. In her current role, Joanne works with client companies on various parenteral product development projects. She also works part time with the DeMontfort University Quality by Design team in a business development capacity and as a Lecturer on their postgraduate MSc programme.
Keith Wickert B.Sc (Hons)
Mr Wickert is Technical Manager for Amazon Filters Limited. He is responsible for managing new product development and technical support, including supporting internal and customer validation projects. He has served on various Pharmaceutical Industry committees including the PDA, IMechE Pharmaceutical Group and Parenteral Society and presented at numerous international conferences. Keith has worked with the Pharmaceutical industry for over 40 years and before he joined Amazon Filters held a variety of Management positions in Production of Pharmaceutical Products, supply of critical equipment and Compliance Consultancy.
Andy Donnelly Ph.D.
Andy Donnelly has 20 years of experience working within the field of parenteral science and joined Bespak"s Innovation Group in September 2013 as an Innovation Manager, helping to develop next generation delivery devices to meet the ever increasing requirements of the pharmaceutical and biotech industry. Previously Andy was based in the USA where he established and subsequently led MedImmune"s drug delivery and device development group, responsible for evaluation and development of innovative device and formulation drug delivery technologies. Prior to this, Andy spent over 12 years working in AstraZeneca"s formulation development groups in both Sweden and the UK, work that included both small and large molecules. Andy has a degree in Pharmacy and a Ph.D. in drug delivery from the Welsh School of Pharmacy UK
Eddie J French Ph.D.
Eddie French of TEKH Consulting Ltd, is an independent pharmaceutical consultant who specializes in therapeutic product design and development. Eddie has 25 years experience in the pharmaceutical industry. The majority of this time was spent with Pfizer as a director within Pharmaceutical Sciences, focusing on drug delivery and drug product development. This included 9 years leading a global team formulating proteins, peptides and nucleic acids. Eddie has a PhD in drug delivery from the University of Bath where he was also a lecturer in pharmaceutics, prior to his industrial career. Eddie is a previous chair and is currently on the advisory board of the Academy of Pharmaceutical Sciences of Great Britain. He is an honorary professor in biopharmaceutical development at the University of Bath and the special professor of formulation at the university of Nottingham
Graduates, Managers, Scientists and Technical staff in industry or hospitals who wish to develop an overall understanding of the formulation and manufacture of parenteral products. This includes scientists in QA/QC and Regulatory Affairs. The course will be particularly useful for staff that are transferring or changing responsibilities to a role involving the development and manufacture of parenteral products.
‘Good overall presentations with quality speakers’
‘All the presenters were skilled and perfectly answered all the questions’
