Partners
Katie M. Dale
Executive Quality and Regulatory Compliance Consultant
Read Katie's Bio Here
Katie M. Dale is a passionate Executive Quality and Regulatory Compliance Consultant who has a diverse background of more than two decades of global experience in RA (Regulatory Assurance), QA (Quality Assurance) and QC (Quality Control) in the medical device, pharmaceutical, and specialty chemical industries etc. Expertise includes quality systems implementation, regulatory compliance, remediation, auditing, trainer, and technical reviews to list a few. She is known as a problem solver with a practical approach in resolving complex issues; she is sometimes referred to as the fixer. She is someone who has a proven ability to implement, coordinate, and manage complex projects simultaneously.
She provides support to a wide range of manufacturers in the navigation of the regulatory environment, with an emphasis on providing proven benefits of compliance in the growth of their businesses.
Through her extensive regulatory and lead auditor experience, she has managed numerous systems and regulatory transitions with a, focus on engagement, collaboration and sustainability basis with key stakeholders across all levels of the organization, with her earnest belief that we are all in this together.
She holds extensive certifications in the following areas:
GMPGXP, MDSAP (Medical Device Single Audit Program) along with EUMDR (European Medical Device Regulation) and IVDR (Invitro Diagnostics Regulation); Lead Auditor, Internal Auditor, Risk Management (ISO 14971), QMS (Quality Management Systems), ISO 13485, CAPA Corrective and Preventive Actions), Supplier Management, Document Control, Complaint Handling, Production and Process Control, Process Validation, Design Controls, Data Integrity, Non-Software; Clinical Evaluations Reports,
Katie M. Dale is a proud Graduate of Niagara University, from whom she holds a Bachelor of Arts degree in Biology.
“She looks forward to availing her experience and skills in taking you and your organization to the next level of success.”
SPHR, SHRM – SCP
Read Rhonda's Bio Here
Ms. Caldwell is the Principal and Founder of RC2 & Associates, LLC; a firm specializing in meeting organizational needs for structured Human Resources, Collaborative Teams, and Impactful Leadership. Whether it’s a small or mid-size business owner, a corporation, a nonprofit organization, or the federal government, she provides customized expertise in a congenial and professional manner. She serves clients in many ways including, but not limited to Human Resources Administrative Services, Intra and Inter Departmental Team Workshops, as well as Executive, Leadership, and Management Coaching.
HERE’S HOW RC2 CAN HELP YOU, YOUR ORGANIZATION, OR YOUR BUSINESS
One on One Executive Coaching for senior leaders, upper management, and rising organizational leaders. RC2 creates a tailored experience that results in more focused, confident, and goal-oriented individuals who are better equipped to navigate organizational challenges.
Customized training workshops for leaders and teams that stimulate greater self-awareness, personal clarity/focus, and collaboration which contribute to a positive and healthy organizational culture. Areas of expertise are leadership competencies, strategic planning, goal-setting, and effective team dynamics.
Interactive and Engaging Activity Facilitation for business and corporate meetings that promotes a greater sense of community and cohesiveness between and among participants and serves to “warm up” the group for the business ahead.
Business Coaching and Consulting for business owners who desire a greater sense of clarity and direction related to taking their business to the next level; their leadership style and its impact on the business; and Human Resources matters such as hiring, onboarding, organizational policies and procedures.
EDUCATION & CERTIFICATIONS
Ms. Caldwell holds a Master of Science in Human Resources Management from the University of Maryland Global Campus and Bachelor of Science Degree in Health Education from the Pennsylvania State University.
She also holds certification as a Senior Professional of Human Resources (SPHR) from the Human Resources Certification Institute and a Senior Certified Professional from the Society for Human Resources Management (SHRM-SCP) as well as Executive Coaching Certification from the Center for Executive Coaches. In addition, she is an Everything DiSC® Certified Practitioner.