The safety and wellbeing of our attendees is a top priority for PDA; therefore, we will be implementing the following guidelines for training courses:
To attend this training course, you must provide proof of vaccination. Accommodation may be offered on a case-by-case basis for any in-person attendee who is unable to be vaccinated due to disability or medical condition, or in connection with a sincerely held religious belief or practice. Attendees that are unable to meet the vaccine requirement or fail to supply an accommodation request will not be granted admittance to the training course. Attendees that are unable to meet the vaccine requirement or fail to supply an accommodation request will not be granted admittance to the training course.
The following are acceptable types of proof of vaccination:
If mandated by national, state, or local guidelines in effect during the dates of any training course, PDA will require masks to be worn indoors regardless of vaccination status.
PDA will be making decisions on additional precautionary measures closer to the date of the training course and in accordance with the latest CDC guidance, local requirements, and hotel policies.
The days of the stern-faced auditor conducting an intense audit and creating a stressed-out auditee are over… or should be! Common sense tells us that just as the pharmaceutical industry has changed, so must the audit. While the goal of the audit remains the same (i.e., a systematic and independent examination to determine whether quality and related activities within an organization demonstrate a state of control), its primary objective is to benefit the function being audited. The success of this objective is dependent on both the auditor and the auditee. This one-day training course journeys through the adventures of an audit and will tour three themes: communication, preparation and credibility.
Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.
Kerry Potter gained his pharmaceutical manufacturing (API and Finished) experience during his 28-year career with Merck in Elkton, Virginia. Kerry’s career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included project manager of laboratory assessment, FDA Quality Management System implementation, and GMP training (annual, ongoing, new hire); administrator of site quality performance, OSHA regulations and Process Safety Management training, as well as internal and external public relations.
He has received qualifications and certifications in the areas of facilitation and training, including instructional design and competency-based curricula. Kerry also received local and national awards for chapter management during his tenure as President of the Blue Ridge Section of the American Society for Quality Control, now the ASQ. Other current and past affiliations include Association for GXP Excellence, American Society for Training & Development, PDA, GMP-Training & Education Association, and Association for Quality & Participation. He is also a certified Pro-Trainer and facilitator, and an Advanced Toastmaster (www.toastmasters.org).
In 2006, Kerry founded Summit Consulting, Inc. in order to offer a combination of business and hands-on consultation, training and mentoring services for the pharmaceutical manufacturing industry. This combination is founded on the areas of project management of regulatory compliance and quality systems; quality assurance; quality systems audits; change control; laboratory testing; design and presentation of regulatory training; employee development; GMP and documentation; and regulatory agency interaction and communication. Kerry serves as the principal consultant of Summit and is currently supporting clients with Quality Systems remediation efforts, and GMP mentoring for pharmaceutical and API manufacturing. He also facilitates public and private on-site training seminars on regulatory compliance topics, both domestically and in Europe.
This training course is intended for professionals who are involved with internal audits.
Departments Quality Assurance, Manufacturing, Quality Control, Regulatory Affairs
Roles Auditor, Auditee, Specialist, Analyst, Supervisor, Manager, Director
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
4350 East West Highway, Suite 110 Bethesda, MD
The following hotels are located near the training course location:
Hilton Garden Inn 7301 Waverly Street Bethesda, MD 20814
Hyatt Regency Bethesda One Bethesda Metro Center Bethesda, MD 20814
Residence Inn Marriott Bethesda Downtown 7335 Wisconsin Avenue Bethesda, MD 20814
DoubleTree by Hilton Hotel Bethesda 8120 Wisconsin Avenue Bethesda, MD 20814
Please visit the hotel's website for more information.
The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).
There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.
Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.
Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.
* For this member type or discount, online registration is not available, please contact [email protected].
Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].
For your credit card information safety: Please send your details by fax only
For an easier registration, please note the helpful hints on the registration form
If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.
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Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.
Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.
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Tel: +1 (301) 656-5900 [email protected]
Tel: +49 (0) 30 43 655 08-10 [email protected]
Tel: +1 (301) 656-5900 ext. 115 [email protected]