Attend Our Training Workshop: Preparing for an FDA Inspection

The Regional Pharmaceutical Manufacturing Expo is a one day event that will be a marketplace for manufacturing decision makers to discuss evolving solutions and technological advances in pharmaceutical and biologics manufacturing.

In addition, attendees have the option to attend training workshops and presentations throughout the day with leaders from today’s most innovative and mature service companies. Registration for the training workshops are free for all RPM Expo attendees.

Led by Michael Falkow of the Lancer Group, Preparing for an FDA Inspection will take place from 2:30 PM to 4:30 PM and will include lunch. This workshop is being held courtesy of the Mercer Institute of Management & Training and the Project Management Institute, New Jersey Chapter. Below is a summary of the workshop:

Attendees will learn the roles of a company in preparing for an FDA inspection and actions during an FDA inspection (both your company and the FDA).  Attendees will also learn the Establishment Inspection Report (EIR) response procedure, some common inspection findings and common inspection follow-up actions.  How to respond to a list of inspectional observations (FD Form-483) will also be presented.

Outline:

  • Why FDA inspections are performed and the different types of inspections
  • The different types of FDA inspections
  • Overview of the inspection process
  • How to efficiently prepare for and perform during an inspection
  • Inspection report response procedures
  • Common inspection observations

    The RPM Expo will serve as an opportunity for decision makers to gain access to the resources required to implement effective solutions in today’s highly regulated environment.

To complete your complimentary registration for this training workshop, please click here. Registration for training workshops includes lunch and full access to the Expo and plenary sessions.

Attend Our Training Workshop: The Key Role in Project Management

The Regional Pharmaceutical Manufacturing Expo is a one day expo style event that will be a marketplace for manufacturing decision makers to discuss evolving solutions and technological advances in pharmaceutical and biologics manufacturing.

In addition, attendees have the option to attend training workshops and talks throughout the day with leaders from today’s most innovative and mature service companies. Registration for the training workshops is free for all RPM Expo attendees.

Led by Michael Sarachman, Senior Director, Standards Management & Technology at GS1, The Key Role in Project Management will take place from 2:30 PM to 4:30 PM. This workshop is being held courtesy of the  Mercer Institute of Management & Training. Below is a brief summary of the workshop:

Biopharma companies spend significant time and resources developing new therapies. Once these therapies have been approved, the challenge of bringing these products to market becomes the next organizational goal. This can only be accomplished through collaboration across functional, organizational and physical boundaries. Project management tools and methods present the opportunity for biopharmaceutical companies to accelerate this process, bringing new therapies to market more rapidly, concisely and efficiently.

Project management methods and tools share many characteristics across industries. Biopharmaceutical practitioners need tools and processes that will enable them to deliver on management, healthcare providers and patient expectations. This session will examine project management practices that have a track record of enabling successful project execution, as well as tools and methods that are worth your time, and those that may not be worth the hype.

Outline: 

  • Successful Cross-Industry Project Management Methods
  • Methods that deliver on management, healthcare providers, and patient expectations
  • PM Methods BioPharma Should Avoid

The RPM Expo will serve as an opportunity for decision makers to gain access to the resources required to implement effective solutions in today’s highly regulated environment.

To complete your complimentary registration for this training workshop, please click here. Registration for training workshops includes full access to the Expo and plenary sessions.

Attend Our Training Workshop: Change Management in Pharmaceutical Manufacturing

The Regional Pharmaceutical Manufacturing Expo is a one day event that will be a marketplace for
manufacturing decision makers to discuss evolving solutions and technological advances in pharmaceutical and biologics manufacturing.

In addition, attendees have the option to attend training workshops and talks throughout the day with leaders from today’s most innovative and mature service companies. Registration for the training workshops is free for all RPM Expo attendees.

Led by Michael Falkow of the Lancer Group, Change Management in Pharmaceutical Manufacturing will take place from 12:00 – 2:00 PM with lunch included. This workshop is being held courtesy of the Mercer Institute of Management & Training and the Project Management Institute, New Jersey Chapter.

During this training workshop, registrants will learn the roles in sponsoring successful changes. Change management and some common sponsor pitfalls will be presented. This workshop is directed both for people who are dealing with change management issues for the first time and for more experienced people who want to review how they managed their change management experiences.  Attendees will also learn the procedure for a system and description of the overall approach to documenting, assessing impact and approving changes to methods, processes, controlled documents, instruments and equipment.

Outline:

•    The value of change control
•    Role in sponsoring successful change control
•    Assessment of key leadership/sponsorship factors
•    The change control process
•    The quality system approach to change management

The RPM Expo will serve as an opportunity for decision makers to gain access to the resources required to implement effective solutions in today’s highly regulated environment.

Attendees can register here for complimentary training workshops at RPM Expo. Registration for training workshops includes full access to the Expo and plenary sessions.