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New Services Address Growing Needs of the Pharmaceutical and Dietary Supplement Industries

BOSTON, Mass. – David Begg Associates (DBA), an NSF International Company, today announced new analytical service offerings for the pharmaceutical and dietary supplement industries. DBA Analytical, the laboratory division of DBA, provides manufacturers with additional analytical testing and consulting service offerings.

NSF International acquired DBA in September 2007 to expand its unique pharmaceutical service offerings worldwide. DBA offers a broad range of pharmaceutical solutions and expertise in quality management, Good Manufacturing Practices (GMP) and regulatory compliance issues, as well as high-quality training for their staff.

"With DBA Analytical, we can now provide manufacturers with accredited testing services,” said Lori Bestervelt, Ph.D., NSF International Senior Vice President & Chief Technical Officer. “With state-of-the-art laboratories in Ann Arbor, Michigan, including an extensive array of instrumentation, we can accommodate client needs for routine analysis, custom analytical method development, testing and stability services.”

These services, which help pharmaceutical manufacturers stay ahead of new regulatory requirements, include:

• New Dietary Ingredient (NDI) notifications: If a company is planning to use an ingredient that was not used in a product prior to October 1994, the FDA requires that the company submit a safety assessment (NDI Notification) verifying that the ingredient is safe for human use. This includes developing risk assessments, appropriate toxicology studies and submission preparation for a NDI Notification.
• GMP services: GMP consulting, auditing and training services help dietary supplement manufacturers develop and implement a management system compliant with the new GMPs. Training seminars are offered several times a year, and on-site training for manufacturers can be scheduled accordingly.
• Stability studies in support of expiration dating: Stability storage and testing to International Conference for Harmonization (ICH) guidelines help manufacturers generate data in support of expiration dating label claims. Stability services include stability study design, determination of appropriate stability-indicating assays and interpretation of stability data.
• Method development and validation: Assist dietary supplement companies in developing and validating methods.
• Label claim verification: Assist dietary supplement companies with testing related to ingredient label claims to verify ingredients and the absence of contaminants.

In response to the growing U.S. and Canadian demand for in-house and residential professional training, DBA recently opened a new office in Boston. The opening of this U.S. office allows DBA to offer exceptional consulting and training services to pharmaceutical manufacturers and development stage companies at a reasonable cost. DBA Partner Jim Morris oversees the new U.S. team.

“We plan to build on DBA’s reputation for providing practical, value-added solutions, while leveraging our new location and expanded consulting team to assist North American clients,” said Jim Morris. “DBA’s team in the UK and in the U.S. is very experienced and well-respected in the industry. Our team, combined with DBA Analytical’s scientific capability, allows DBA to offer a broader range of services: training, consultancy and now analytical testing.”

For more information on DBA Analytical’s new service offerings, please contact Casey Coy at CCoy@DBA-global.com or +1 734-913-5734.

About David Begg Associates: Established in 1986 to provide expert services to the pharmaceutical and biopharmaceutical industries, David Begg Associates has an outstanding international reputation in the field of pharmaceutical quality management, regulatory compliance and, in particular, high-quality training courses (www.dba-global.com).

About NSF International: NSF International, an independent, not-for-profit organization, helps protect you by certifying products and writing standards for food, water and consumer goods (www.nsf.org). Founded in 1944, NSF is committed to protecting public health and safety worldwide. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment. Additional services include safety audits for the food and water industries, management systems registrations delivered through NSF International Strategic Registrations, organic certification provided by Quality Assurance International and education through the NSF Center for Public Health Education.

As you are probably already aware, in February 2009 the EMEA issued a revised Reflection Paper that updates the one issued on this topic in 2006.  A copy of this revised version is attached where I have highlighted the changes to make them clear for you.

It is very disappointing that none of the points raised by industry at a meeting in September 2007 between the EU Inspectors Working Party (IWP) and industry ‘interested parties’ are addressed in this revision of the reflection paper.  Indeed, one of the changes is to make it clear that ‘Planned Deviations’, which industry asked to be included within the scope of the Reflection Paper, are specifically excluded.

The 2009 Paper does state “This Reflection Paper has been revised to take account of comments made and experience gained. It has been done to improve understanding based on feedback from industry and regulatory authorities. A number of comments from this feedback were received that cannot be taken forward at this time but may be addressed in the forthcoming revision of the Variations legislation.”  So it is possible that some recurring deviations may be type 1A Variations under the new system but this is not effective yet and the Guideline that lists the changes that will be type 1A and type II variations has yet to be published.

So to summarise, this revised Reflection Paper has changed very little from the 2006 position, other than tightening up in some areas.  It is likely that the significant differences in approach to the subject of the discretion QPs that are permitted by individual Member State authorities will continue; with the UK and Ireland adopting the most dogmatic stance.

GMP for Biological and Biotechnology Products

Manchester Marriott Victoria & Albert Hotel

17 - 19 February 2009

25 delegates from 9 different countries and 15 different companies and institutes attended our 3 day course on biologicals and biotech products in Manchester recently, and the feedback was great!  The delegates scored the course 4.5 out of 5 and everyone had a really enjoyable - and informative - time.

“Very useful. Buzz groups really good”

Louise Groth Hansen, Novozymes, Denmark

“Excellent course with great, highly experienced tutors”

Sam Corveleyn, UCB Pharma, Belguim

“Very good course!”

Maria Kildal Haugum, Pharmaq, Norway

We received equally good feedback when we hosted this course in the USA in late 2008, and also when we have delivered it in-house for companies in the US and Europe.

We do not plan to hold the course again until Spring 2010, but if you would like to explore the possibility of us performing the course at your company, please contact us.

Our first course on ‘Risk Based Decision Making for Quality Professionals’ was an outstanding success. The delegates we’re an experienced group…each had worked in the Pharma industry for an average of 18 years!

The feedback we received was reassuringly good. The average score for ‘course satisfaction’ was 4.34 (maximum score 5.00). Everyone enjoyed the mix of lectures, introducing some novel tools and techniques, combined with numerous case studies and exercises. These ‘real life’ problems really challenged the group’s decision making skills. The companies represented should feel privileged ….they posses some very good decision makers!

Risk Based Decision Making: Key Points

For those unable to attend here are some of the delegates ‘Key Learning Points’

• ‘NEVER make a decision with a high level of uncertainty….it will be wrong!’
• ‘Remember, our brains are designed for speed, not accuracy. Most decisions are based on emotion…not fact, even for ‘scientist’
• ‘Always use a structured approach to decision making, no matter how little time you have. The process described on the course really does work’
• ‘Use the tools covered on the course, they are invaluable’
• ‘The session on ‘grey area decision making’ was exceptionally good’

Manufacturing medicines is easy until things go wrong. Making the right decision is always difficult …particularly when information is spares and the stakes are high. After all, the consequence of making the wrong decision can be catastrophic.

‘In House’ Course Customisation

DBA have successfully run this course ‘in house’ for a number of companies allowing us to customise content to suit your specific needs and requirements. If you would more information please contact Martin Lush (mkl@DBA-global.com)

‘Where ever you see successful business you see skilled decision makers’

                                                                                  Peter Drucker: Management Guru

If pharmaceutical companies are to meet the ever-increasing regulatory and business challenges they face in today’s climate, they will need high calibre Quality Professionals throughout the organization and to help the business meet and conquer these challenges and act as change agents through periods of transition.

These Quality Professionals will need the following skills and attributes:

·        A comprehensive knowledge and understanding of pharmaceutical legislation – domestic and international – and the compliance issues that face the company and all its staff

·        A clear understanding of all the factors which can affect the intrinsic and extrinsic quality of a medicine and how these must be controlled during manufacture

·        The ability to use this knowledge to assess risk (to the patient and to the business) and to take risk-based quality decisions

·        The leadership skills to communicate decisions effectively, prevent or manage potential conflict and to manage change

Sadly, we are not born with these skills and attributes – they must be taught – and there has been no one organization which can train your key staff in all of these crucial areas: UNTIL NOW!

The skills described above are essentially those required by the Qualified Person in Europe – someone nominated by the pharmaceutical company and formally authorised by the regulatory authorities as being legally responsible for the quality of each and every manufactured lot of medicine or clinical supplies.  For the past 19 years, David Begg Associates has provided industry leading training to people wishing to become Qualified Persons and our reputation in this field is second to none.  With our partner, the University of Strathclyde in Glasgow, Scotland, we have helped more than 180 industry professionals to become Qualified Persons throughout Europe.

Over the past 6 years, we have used this experience in Qualified Person training to work with several US pharmaceutical companies to provide tailored, focused training in-house for specially selected staff.  So far, we have successfully completed series of training with two large companies and we have ongoing programs with three more.  The feedback from both delegates and senior management has been fantastic…

“We decided that our USA QA colleagues could benefit from the same formalized training as required for QPs in Europe.  The results surpassed our expectations.  The QA leaders who participated in the training have much greater confidence in their decision-making ability.  DBA provided training that could immediately be used in their daily activities.”

Gerry Migliaccio, VP/TL Global Quality/EH&Sops, Pfizer Inc

“DBA’s course has made a difference in the short term by allowing our delegates to be more efficient in their daily jobs.  Most importantly, DBA has provided them with the skills they will need in the long term to manage change and meet future challenges.”

David Watson, Senior Vice President of Global Industrial Operations, Sanofi Pasteur

Recently, several companies have expressed an interest in putting their Quality Professionals through this training, but they have been unable to identify the numbers of students necessary to make in-house training economically viable.

That is why we have decided to offer this training to North American pharmaceutical companies through a series of open residential training courses, commencing October 2009.

We will follow the tried and tested QP training model which has proved so popular and effective in Europe by offering a series of 12 independent but linked training courses over a period of just under two years.

The training courses will be held at the Royal Sonesta Hotel in Boston.  Each module will last for three days and will cost $2700.00.  David Begg Associates’ accelerated and interactive learning methods will be used to enhance the learning experience during each of the modules. Instructors will be the same DBA industry experts and University of Strathcyclde instructors as in Europe.  Additionally, DBA’s US experts will also be used to ensure that the US regulatory requirements are fully explained.

Delegates attending every module will have the unique opportunity to obtain a Postgraduate Diploma or, if performance is good enough, a Masters Degree in Pharmaceutical Quality and Good Manufacturing Practice from the University of Strathclyde in Scotland.

We will be sending out full information packs on these Quality Leadership training courses in early 2009.  If you would like to learn more about this unique training or reserve a place, call Jim Morris on 616 – 342 2625 or email USinfo@DBA-global.com

We are delighted to announce that DBA will be opening a US office from October 1, 2008.

The office is based in downtown Boston and will be headed by our Partner responsible for US operations, Jim Morris.

Jim joins us from MassBiologics, where he was a Deputy Director of Quality.  Before that, Jim worked as Director of QA/QC Biologics and Parenterals for Cilag AG, a division of Johnson and Johnson, based in Switzerland.  Jim has also worked for Pfizer in a variety of technical roles in the US, Puerto Rico and Italy.  He has extensive industrial experience and an excellent understanding of both US and European regulatory and GMP regulations.

By the time we officially open for business, we will have at least two additional staff; both with extensive US industry experience.

By combining our expertise and resource in Europe with that in the US, we are confident that we can offer you a level of services in consultancy, auditing and training that is unparalleled in the US.

Contact details for our new US office:

David Begg Associates USA LLC

Suite 19

101 Federal St.

Boston, MA 02110

Tel.      617 342 3625

Fax      617 342 3623

Email  USinfo@DBA-global.com

Web    www.DBA-global.com