Industry Expert Learning Series HRDF SBL Claimable
Medical Device Manufacturing Process Validation
The US FDA Quality System Regulation (21 CFR Part 820) and ISO 13485 include requirements for process validation. According to FDA statistics process validation non-conformance is in the top five 483 observations with many manufacturers not satisfactorily having established compliance resulting in adverse FDA inspections including issuance of Warning Letters and Import Alerts. In addition to avoiding the cost of non-compliance, Manufacturers stand to gain from the significant cost savings and improved process controls resulting from validated processes.
Participants will be led by an accomplished tutor with over 2 decades of practical experience in the subject matter gained from auditing, training and quality assurance as well as management system development activities.
Participants will engage in small group activities and lively debate, along with instructor led segments to gain the expertise needed to effectively manage audits. The course is designed to ensure participants fully understand the essential regulatory requirements and technical aspects for process validation.
COURSE OBJECTIVES/ OUTLINE
Process Validation – Approach and Requirements for US FDA compliance and ISO 13485 conformity
Risk Management and Validation
Harmonized Process Validation for multiple market jurisdiction compliance
Which processes to Validate; Which to Verify
The role of Statistical Techniques and Tools in Process Validation
Auditors of Medical Device Supply Chain (incl. assessments on Supplier/Outsource Service Provider)
PRE-REQUISITES Familiarity with ISO 13485 and/or 21 CFR 280 is preferable but not mandatory
DURATION Two (2) full days
PAYMENT Payment is required before/ on training date. Please choose from below options.
Option 1 : Direct Bank-in or via E-Banking upon receipt of Invoice Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice.
Please refer the following bank account details: Beneficiary Name: Medsociate Sdn Bhd Bank Account Number: 800 3930 348 Bank: CIMB Bank Swift Code: CIBB MYKL
Please email us (firstname.lastname@example.org) the bank-in slip / remittance slip once the payment is made.
For Government Sector A Local Order (LO) or letter of approval to participate must be presented before the training.
Option 2 : Direct Online Payment You can choose to make payment via Paypal upon receipt of invoice. When making payment, in the email section, please key in our Paypal Account : email@example.com
SUBSTITUTION Substitution is allowed for a registered participant. No refund will be made for cancellation.
CANCELLATION Medsociate Sdn Bhd (AMMI Authorised Training Provider) reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded if the cancellation is made by training provider. Cancellation of attendance and refund will not be entertained as all bookings would have been reserved and confirmed.
CONTACT For enquiries, please email to firstname.lastname@example.org. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347
This training is organised by Medsociate Sdn Bhd.